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)

 

 

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.