Job Type: contract

Project Co-Ordinator

Ascend PM are hiring a Project Co-Ordinator to join our clients expanding team, a multinational biopharmaceutical company based in Dublin. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie for more information.

Key Responsibilities:

• Ensure the delivery and reporting of project portfolio through the Capital Project Management Process. Managing the project repository on Sharepoint.
• Assist with “Procure to Pay” activities including raising of Purchase Orders and logging and approval of Invoices
• Provide contract administrative support to Project Management team.
• Manage the coordination of internal and external meetings, including travel arrangements.
• Demonstrate superior attention to detail
• Act as a liaison both internally and externally, managing the setup of meetings, and maintaining asense of professionalism at all times.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

Qualifications & Experience:

• Good organizational skills, detail-oriented & accurate, analytical skills.
• Excellent communication skills (both written and verbal), facilitation, and presentation skills
• Self-starter, highly motivated individual that can work under minimal supervision
• Team player that naturally complements with peers, clients and all levels of the organization.
• Works effectively with diverse departmental groups.
• Excellent interpersonal skills that can effectively communicate with peers, clients and all levels of the organization

 

 

Process Engineer

Ascend PM are hiring a Process Engineer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

Overview:

We are seeking an experienced Process Engineer to join our clients team, working collaboratively with Global Device Engineering (GDE) and Manufacturing to design and implement advanced, high-performance manufacturing processes for medical device production. This role involves active participation in multiple projects focused on the development, automation, and testing of medical devices, taking process and equipment concepts through to full-scale implementation on the manufacturing floor.

Key Responsibilities:

• Design and develop robust, high-yield manufacturing processes that ensure consistent product quality
• Optimize equipment and process technologies to support the successful transfer of reliable, efficient processes into full-scale manufacturing.
• Collaborate with GDE teams to support the design and seamless transition of new medical devices from development through validation and into production.
• Manage and support external vendors in the design, build, and installation of manufacturing equipment-from initial concept through to factory integration.
• Drive continuous improvement and innovation in existing equipment and processes to support New Product Introductions (NPIs).
• Prepare and maintain detailed process and manufacturing documentation.
• Author and execute validation and qualification protocols (IQ/OQ/PQ) for equipment and processes.\
• Champion ongoing process improvement initiatives to ensure high standards of product quality and efficiency.
• Coordinate with cross-functional teams to support both current and future manufacturing needs.
• Act as a site-level expert in specific manufacturing technologies and support knowledge development within the team.
• Oversee the commissioning and scaling of new manufacturing technologies, with a focus on microcatheter production.
• Conduct risk assessments with Environmental Health & Safety (EHS) teams when introducing new equipment, materials, or chemicals to reduce environmental impact

 

Education & Experience

• Bachelor’s degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
• Minimum of 5 years of experience in the medical device industry.
• Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.
• Excellent analytical and problem-solving capabilities
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals
• Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.

 

Mechanical Engineer

Ascend PM are hiring a Mechanical Engineer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

Overview:

We are currently searching for a Mechanical Engineer to join our Global Dublin Device Engineering team in a Contract Role. Working within a Matrix Organizational structure, The Mechanical engineer will help develop a new complex medical device.

Key Responsibilities:

  • Support Development Activities for Sustaining and New Product Development 100%
  • Lead Engineering activities
  • Design electro mechanical components and assemblies
  • Design plastic single use parts.
  • Lead in the development of Test Plans and Protocols
  • Execute characterization tests and draft test reports
  • Actively participate as part of a multi-skilled development team
  • Lead Root cause analysis of engineering problems.
  • Develop innovative solutions to engineering problems
  • Construct prototypes; evaluate and document their performance; identify possible improvements
  • Create and implement suitable tests to verify designs meet requirements
  • Lead and Support Technical Reviews for New Product Reviews and Sustaining Product Reviews
  • Responsible for recording and sharing technical knowledge gained with colleagues.
  • Adhere to design control and risk management policies.

 

Experience & Skills:

  • 3+ years’ experience, preferably in a regulated environment
  • BS or MS degree in a scientific or engineering discipline
  • Experience in development of complex devices from concept through to validation activities
  • Hands-on experience constructing mechanical prototypes utilizing rapid-prototyping methods and equipment
  • Proficiency with SolidWorks required
  • Failure Mode Effects Analysis (FMEA) experience a plus.
  • Strong Computer skills (MS Word, Excel, PowerPoint, Outlook, Internet)

 

 

Project Engineer

Ascend PM are hiring a Project Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The Project Engineer is responsible for assisting with the Engineering elements of the expansion project through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.

Key Responsibilities:

• As a member of the Engineering team, support the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.
• Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure requirements are in line with standards and fit for purpose.
• Assist with equipment project deliverables of setup, calibration, spare parts management, functional testing, and start-up support.
• Ensure consistency in equipment design and practices, with a focus on simplifying processes and tasks.
• Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.
• Establish maintenance strategies and develop initial PM programs for process equipment.
• Travel as required to support project execution.

Qualifications & Experience:

• Minimum of a Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical) with typically 4+ years of experience in engineering projects and systems.
• Fundamental knowledge of applicable quality management and regulatory requirements.
• Solid leadership, technical writing, and communication/presentation skills.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in developing strategies for new product introduction and new technology deployment.
• Team player who actively promotes a culture of clear communication, collaboration, and engagement at all relevant levels for effective decision-making.
• Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.
• Strong technical ability to understand and resolve complex problems as part of a focused and high-performing team.
• Experience in vendor management and contract negotiations with a focus on equipment suppliers.
• Independent, self-motivated, organized, and able to multi-task in project environments.

EHS Specialist-Senior

Ascend PM are hiring a EHS Manager to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The EHS Manager is an integral member of the Enterprise EHS Team whose primary responsibility is to manage and provide advanced leadership for successful development, implementation and maintenance of a fit for purpose performing EHS system for the Brands business.

Act as the business Partner for Commercial & Clinical and all OUS activities / employees. This position is responsible for managing the budgeting, implementation, maintenance and continuous improvement of an EHS Management Information System and EHS Auditing for internal and external resources. This position will lead and execute projects, and activities to achieve location and company goals & objectives. The Sr. EHS Manager for Global EHS will also provide EHS tactical support to all Employees following critical business functions: Internal & External Manufacturing Locations, Regional Service Centers, Commercial & Clinical and Corporate Offices.

Key Responsibilities:

• Act as:
o Business Partners for Commercial & Clinical and all OUS activities / Employees
o Business partner for Ireland and Japan.
o EHS lead on integration and divestitures projects
o The ESG Lead for Brands
• Support Brands EHS Business Partners and Site EHS personnel on business needs and regulatory requirements.
• EHS Strategy Development: Lead the development and periodic refresh of the overarching EHS strategy to alignwith the overall company strategy and industry best practices.
• Develop and implement comprehensive strategies, roadmaps, and execution frameworks to drive companysafety priorities.
• Drive accountability across all functions to eliminate accidents and injuries, managing programs to achieve highengagement and ownership at the employee level.
• Engage and influence colleagues at all levels, across all Divisions, to foster a culture of safety and compliancewithin the organization
• Develop, establish and maintain a comprehensive Brands EHS Compliance Audit Program including internal and external (Contract Manufacturing) locations. This includes managing schedules across the corporation, managing budget resources and managing third party vendors utilized to accomplish the goal.
• Drive behavioral awareness across all operations to enhance employee engagement and improve employee’s welfare and psychosocial needs when at work.
• Develop, implement, and maintain the company’s EHS policy, standards, recommended practices, and guidance documents, utilizing best-in-class knowledge management processes
• Lead EHS Projects with notable risks and develop strategy for improvement.
• Resolve complex EHS problems impacting other business functions.
• Collaborate with cross-functional teams to integrate EHS considerations into business processes and decision making
• Oversee compliance documentation and reporting to external regulatory agencies and internal audit teams.
• Implement comprehensive emergency plans and risk mitigation strategies for all sites.
• Implement and maintain a metric/performance reporting structure to ensure transparency of EHS performance, along with key trends, to key stakeholders both internal and external.
• Act as a liaison between EHS and other departments to resolve safety issues and implement policies effectively.
• Own and manage the company’s EHS digital platforms and associated technology to support EHS initiatives and enhance performance
• Using lean principles / process improvement systems responsible for the success integration Brands projects / improvement plans
• Lead the development and implementation of safety and sustainability culture programs to enable successful execution of EHSS programs and achieve industry-leading performance.
• Manage EHS ESG requirements in collaboration with other business functions
• Manages, evaluates and promotes applicable ESG actions according to company or location requirements.
• Establish and maintain robust global governance processes to ensure effective and consistent risk identification and management at all levels of the business.
• Develop implement and maintain a comprehensive audit corrective action creation and tracking program for all audit corrective actions.
• Lead EHS Projects with notable risks and develop strategy for improvement.
• Develop, establish and maintain programs to enhance employee engagement and improve employee’s welfare and psychosocial needs when at work.
• Travel as needed or assigned to internal and external locations (foreign and domestic) for the purpose of implementing and managing assigned programs and systems.
• Ensure local policies and procedures for safe work are developed, implemented and followed at the assigned work locations and groups by tactical engaging with the management team and employees by providing clear directions, communicate and operating practices/procedures.
• Provide EHS technical expertise with the explicit purpose to identify root causes and suggest corrective measures to prevent recurrence of similar incidents in the future.
• Develop and oversee the overall global EHSS training program, including training development and deployment, to ensure respective colleagues are knowledgeable and compliant with EHSS standards.
• Stay current with industry trends, regulatory changes, and best practices in EHSS to ensure the company remains at the forefront of EHSS performance across audit, systems and performance.
• Implement and lead EHS related committees for assigned locations and organizations such as Q&Ops EHS Council & International EHS Council
• Reviews new process/equipment or new construction and/or building modifications for EHS impacts and collaborates with appropriate project teams in developing corrective actions to address findings.
• Reports to VP Global Quality, serving as the Sr. Manager for the Brands Business Unit
• Financial responsibilities include managing assigned operating budgets and collaboration with assigned Location/Organization leader budget/spend approvals.
• Occasional travel (US / international) is expected for this position

Education & Experience:

• Bachelor’s degree in EHS or related Science field is required. Equivalent documented experience in EHS practice may be considered.
• A required minimum of 15 years’ experience in EHS function preferably within a Manufacturing, Facilities Management and/or Research Laboratory setting with direct responsibility for EHS activity.
• Thorough understanding of EHS science; analytical and problem-solving skills; strong communication skills
• Expert knowledge of EHS regulation with strong understanding of International Safety, Health and Welfare Laws
• Ability to anticipate and foreseen business and regulatory issues
• Experience in leadership positions and ability to manage complex operations, projects and change resistors.

Project Manager (Supply Chain)

Job Description:

The External Supply Device team based in Dublin, has a requirement for a Project Manager to support projects in readiness for launch of high-volume supply of autoinjectors to the commercial market.

Key Responsibilities:

• Understand the scope of work for each project as defined by the Director for Device Supply
• Develop project charters aligned with scope of project
• Establish resources required for successful execution of projects
• Develop and manage project plans with clear objectives and milestone dates
• Engage with internal and external stakeholders for successful execution of projects
• Establish and maintain dashboards / scoreboards for each project to manage and communicate status
• Apply lean methodologies in execution of projects and apply a lesson learned approach in the interest of continuous improvement
• Defining and implementing an appropriate SKU strategy
• Ensuring device specification requirements are met during manufacturing, storage, handling and transport
• Implement an injection molding tooling maintenance and replacement strategy
• Identify and implement improvements for volume scale up projects
• Ensure suppliers meet receiving sites requirements
• Streamlined procurement, manufacture, supply and payment processes

Qualifications and Experience:

• Bachelor’s Degree in a Science, Engineering or Supply Chain discipline
• Project management experience in pharmaceutical operations
• Experience in medical devices with specific understanding of MDR’s
• Knowledge and experience in application of continuous improvement, operational excellence methodologies such as lean six sigma

Process Engineer

Ascend PM are hiring a Process Engineer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

Summary

Reporting to the engineering services lead, the process engineer is the primary owner for process equipment within the clean room areas and associated utility systems in a GMP regulated manufacturing setting. The process engineer plans and manages day-to-day technical support and planned and unplanned work on process and associated
equipment including facility support to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient. The process engineer is also responsible for the requalification and life cycle management of the qualified equipment onsite. The process engineer will also be responsible for supporting the identification and implementation of continuous process improvements.

Key Responsibilities

• The position requires effective cross-functional collaboration with internal partners including Site Engineering, Facilities Management, Manufacturing Operations, Technical Operations, and Quality and external contractors.
• Manage all process engineering activities and utility activities to meet and optimize manufacturing schedules while maintaining a high level of GMP compliance and cost efficiency.
• Manage process engineering activities includes all planned and unplanned works on process equipment.
• Corodinates with maintenance all utilities equipment activities including all planned and unplanned works on utility equipment associated with the clean areas.
• In addition to vendor training provide training to the process and utility technicians on process equipment.
• Collaborate with the maintenance and utlities lead to optimise the preventative maintenance program across process and utility systems including a review of executed maintenance activities and identify improvements to the maintenance job plan content.
• Implement equipment and maintenance reliability improvements. Development and implementation of area / equipment improvement plans to repeat failures and other maintenance problems.
• Life cycle management of the validation of qualified equipment and ongoing process engineering support for this equipment.
• Provide support to Manufacturing, Validation, and Maintenance on process equipment and utility systems when required.
• Manage all process engineering and validation activities associated with qualified equipment on site.
• Coordinate with quality and other areas on the requalification program.
• Manage vendors supporting/executing the works.
• Provide Engineering expertise in trouble shooting activities to support manufacturing during process transfer activities or deviation investigations.
• Provide support and participate in regulatory inspections.
• Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
• Identify and support process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing support equipment.
• In conjunction with approved vendors, research new processes and/or systems for maintenance/manufacture of equipment and implement new processes and systems as developed under the direction of the Operations Manager.
• Acts as an advocate for engineering continuous improvement activities.
• Ownership and tracking of engineering key performance indicators (KPI’s) for the utility areas.
• Take the lead in troubleshooting and problem solving on process equipment while providing coaching and mentoring to other engineering, maintenance and operations staff.
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to utility equipment/systems.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Promote regulatory compliance and alignment of the site with the Business Unit Engineering strategies and objective.
• Ensure a commitment to safety, quality and operational excellence at a competitive cost. Understand system reliability and availability and manage any scheduled or unscheduled down-time and the associated risk.
• Participate in the on call process when rostered with oversight and responsibility for all site activities out of hours.

Education / Experience / Skills:

• A third level degree in Process Engineering or equivalent experience
• Relevant experience working in a technical engineering role in the Pharmaceutical / Biotechnology industry.
• Evidence of continuous professional development.
• Team leadership experience.
• Experienced in identifying priorities for assignment of resources and time.
• Experienced in the application of lean principles and structured problem-solving techniques.
• Strong technical capabilities, communication skills, teamwork abilities and initiative.
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Organized analytical thinker with strong attention to detail
• Excellent oral and written communication skills, including technical writing
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Must have good verbal and written communication skills. Ability to present and explain data to both technical and non-technical forums.
• Collaborative teamwork philosophy and demonstrated positive interaction with others.
• Mature judgment in problem solving situations.
• Independent decision-making abilities with strong results orientation mindset.
• Rigorous attention to detail.

Technical Writer Med Device

Ascend PM are hiring a Technical Writer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

 

Overview:

An experienced technical writer with a track record of developing user-friendly, comprehensive documentation. You will work within the Global Device Engineering department supporting the creation of medical device operator manuals and technical documents. Deliver content to support the delivery of state-of-the-art software solutions & GUI’s.

Job Responsibilities:

• Develop and edit medical device labelling content (e.g., user manual text and design, device labels) that is easy-to-read and understand by end users.
• Collaborate closely within a cross-functional team (with Regulatory Labelling, Quality, Clinical, Human Factors, Commercial, Engineering, Regulatory etc.) to optimize medical device labelling clarity and completeness.
• Translate technical jargon into user-friendly language to ensure documentation is accessible to a diverse audience.
• Extract relevant information from complex engineering documentation for use in clinical instructions, including working autonomously with limited direction.
• Understand regulatory requirements for medical device labelling, and develop labelling to meet these.
• Research new operator manuals, modifications to existing manuals, technical bulletins and other written material. Edit documentation written by others.
• Develop labeling for all medical devices and accessories.
• Stay up to date with product updates/changes, collaborating with development teams to ensure accurate and timely documentation
• Work within the defined company processes to ensure compliance.
• Conduct reviews and updates of existing documentation to reflect changes in software or hardware configurations.
• Support external language translations.

Job Requirements:

• Five (5) plus years Technical Writing experience.
• Excellent writing and editing skills, with a keen eye for detail and clarity.
• Demonstrated experience of producing medical device labelling content compliant with US and/or EU regulations and standards.
• Ideally experience using common technical writing tools (e.g., Adobe Creative Suite and MS Word, Excel, PowerPoint etc.).
• Knowledge of documentation quality management systems is desirable. Mastercontrol experience is an advantage.
• Excellent problem-solving methodology, using industry-accepted concepts and tools to solve complex problems in creative and effective ways.
• Comfort working in fast-paced, results-driven environments with tight timelines and frequent changes.

Program Project Manager

Ascend PM are hiring a Program Project Manager to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

Overview

The Program Project Manager is responsible for providing comprehensive project and support function scheduling and project management support to the Manufacturing Facility. The program/ project manager must ensure that project objectives and milestones are effectively achieved and consistent with requirements to ensure compliance, safety and efficient project execution.

Roles and Responsibilities

• Development and maintenance of an integrated project schedule to include Engineering, Operations, Quality and Project activities, highlighting key milestones.
• FDA Audit readiness
• Capital Project Program
• Continuous Improvement Projects
• 5 year strategic projects including enterprise production schedule, site development plan
• Establish and effectively manage information management systems, develop reports, presentations, project updates, schedules and timeline updates and correspondence utilizing many different computerized systems.
• Use standard systems including MS Word, MS Project, Excel, PowerPoint and industry/ company specific software for project management, document tracking, reporting, etc.
• Maintain overall program schedule, review and communicate detailed critical path schedules.
• Ensure co-ordination of detailed schedules highlighting resource and deliverables loading.
• Provide effective administrative support to facilitate efficient project management. This may include tasks such as analyzing and reviewing data and compiling summary documents.
• Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
• Be a document system expert; this will include document review, approval and document system work flow expedition.
• Support divisional activities through documentation generation, filing, tracking, auditing and maintenance of associated databases.

Experience, Qualifications and Education Requirements

• Degree / diploma level qualification in Project Management or Engineering plus 10 years’ experience in the Pharmaceutical industry or a similar operating environment.
• Experience with dealing with plant leadership level stakeholders
• Scheduling systems: Primavera, MS Project planning experience.
• Technical cGMP pharmaceutical knowledge and experience of project execution logic.
• Proven application of various planning methodologies used on Facility Construction and Process Equipment development and integration projects.
• Experience of working in professional service company.
• Experience in planning activities within the confines of stringent EHS processes.
• Experience of operating within a Computerized Maintenance Management System (CMMS).
• Experience in the application of lean principles and structured problem-solving techniques.
• Demonstrated ability to identify improvement initiatives.
• An ability to work independently and as part of a team. The successful candidate will be able to organise their own work on a routine basis and requires minimal supervision.
• Experience in working in cross-functional teams.

Validation Engineer

Ascend PM are hiring a Validation Engineer to join our clients team, a biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The Validation Engineer will be responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.

Key Responsibilities:

•Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
•Pre-Approve and Post-Approve validation protocols.
•Input into site Validation Master Plans and Standard Operating Procedures (SOP’s)
•Collate and Report on relevant validation data/metrics.
•Assist in exceptions and deviation resolution and root cause analysis.
•Reviews Validation planning documents detailing overall strategy for the project.
•Reviews and Approves Qualification summary reports (QSR)
•Generates Validation Summary reports.
•Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Education / Experience:

•6+ years experience in Engineering or Validation
•Technical qualification at third level or equivalent in Engineering.
•Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects
•Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
•Knowledge of safety and GMP requirements.
•Demonstrated strong Communication skills
•Experience using Paperless Qualification Systems is preferred.
•Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry

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