Job Location: Dublin

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

 

 

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.

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

Senior Project Manager

Ascend PM are hiring a Senior Project Manager 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 Senior Project Manager will lead project teams and interact across functional and site department groups to achieve project objectives. These capital projects could include new builds, facilities/utilities system and/or equipment lifecycle replacements, upgrades, manufacturing improvements and changes to support New Product Introductions. The candidate will lead all aspects of their project(s): Safety, planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up.

Key Responsibilities:

• Project management and delivery of projects including project planning/scoping and execution, prioritization, resources management, status management and external communication through the Engineering Project Delivery Process.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Managing expectations and communicating project progress and challenges to these stakeholders.
• Develop and/or review engineering technical specifications and bid documents for engineered equipment, materials engineering, and construction service contracts
• Lead day to day design (where applicable) and construction management of project works, including procurement, installation, and commissioning
• Provide engineering support for manufacturing processes and equipment within the manufacturing facility by designing, specifying, purchasing and constructing mechanical systems and components (with the aid of an A&E firm where required).
• Implement and maintain quality control processes to ensure that installations and deliverables meet industry standards and client expectations.
• Strategic solution seeking to complex project phasing and execution issues. The Project Manager will be responsible for their portfolio of projects from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new equipment including driving the project team problem solving and troubleshooting process prior to qualification & start-up
• Leader of multidisciplinary site teams
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Role model safety leadership. Support a safe working environment by driving compliance with environmental health/safety practice, rules and regulations. Ensure projects are designed with superior levels of environmental control, health and safety built in.
• Supervise contingent workers as needed. These workers include construction managers and all general craft labour and A&E firm personnel
• Support team members in the management of third party contractors and outsourced partners to ensure the optimal delivery of portfolio against safety, cost, quality and schedule objectives
• Works with Project Controls to manage and report on the Capital Budget for the assigned project.
• Present projects to senior leadership at governing bodies for updates and approvals
• Limited travel may be required to support execution of projects

Experience and Qualification:

• Bachelor’s Degree in Engineering or Relevant Experience
• Typically, 5+ years project management/engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment
• Proven project management experience from project inception through to handover
• Strong technical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills
• Data driven decision maker
• Ability to work to tight deadlines in a fast-moving environment

Senior Engineer

Ascend PM are hiring a Senior 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:

This opportunity is part of the global Process Development organization. This role will require the candidate to support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. Depending on assignments, the candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials) and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.

Key Responsibilities:

• Develop as a drug product technical expert, to provide leadership and solutions troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
• Work with contract manufacturing partner SME’s, Global Operations, Contract Manufacturing Quality and drug product process teams.
• Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational improvements for current and new sterile operations.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to observe production operations and build relationships
• International travel will be required to visit contract manufacturing partner sites in Europe.

Experience & Qualifications:

• 3 -5 years’ pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
• Knowledge of cGMP’s
• Third level bachelor’s degree in Science, Engineering or a relevant quality discipline
• Language skills such as Italian or German.
• Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
• Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
• Experience with the quality testing methods and interpretation of results for biological molecules
• Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
• Experience dealing with contract manufacturing organisations
• Project management experience

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 / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Filter/Filter Integrity Testing areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.

Key Responsibilities

• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
• Ability to translate strategic/emerging technology solutions into pragmatic executable plans
• Development and management of change controls
• Participate as a member of multidisciplinary site and multisite teams
• Development of detailed specifications, engineering documents, protocols and standard operating procedures
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
• Support a safe working environment by complying with environmental health/safety practice, rules and regulations
• Travel may be required to support execution of projects

Experience and Qualification:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
• Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly
• Proven project management experience.
• Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• Experience in MS Office, MS Project, Change Control & Document Management Systems
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills

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