A leading biopharmaceutical company is seeking a Process Engineer III to provide process engineering services in support of the design, commissioning, and qualification of an expansion to an existing bulk vaccine processing facility. The Process Engineer III will work closely with the process engineering team as a client owner representative to deliver the project objectives.

This role involves leading cross-functional teams to manage the following:

• Equipment package design, factory acceptance testing, installation, and commissioning
• Equipment packages may include Product Vessels, Single Use Mixers, Single Use UFDF skids, and CIP/SIP skids.

KEY RESPONSIBILITIES

• Support the process lead to implement process design based on project scope and requirements.
• Lead and manage cross-functional project teams to ensure project goals are met and stakeholders' requirements are reflected in C&Q (Commissioning & Qualification) deliverables.
• Ensure all project stakeholders are informed and consulted on key process activities and decisions.
• Monitor progress, milestones, and provide regular status updates to project tiers and stakeholders.
• Oversee C&Q progression in collaboration with partner firms.
• Ensure adherence to engineering standards, procedures, and best practices.
• Support and, at times, lead the preparation and execution of C&Q field activities.
• Develop and/or review system lifecycle documents, including Criticality and Risk assessments, FAT (Factory Acceptance Testing) documentation, and C&Q documentation.
• Manage installation, startup, and testing of process systems through OQ (Operational Qualification) completion. Interface with cross-functional teams to ensure readiness for systems post-OQ (e.g., PQ, PPQ).
• Liaise with stakeholders, equipment vendors, business partners, and subject matter experts at other facilities as required.
• Prepare project-related deliverables, including schedules, work plans, and equipment cost tracking.
• Coordinate project activities and ensure smooth collaboration between various stakeholders.

KEY REQUIREMENTS

• Minimum qualification: B.Sc., M.Sc., or M.Eng degree in Chemical Engineering, Biochemical Engineering, or a related field (e.g., Biotechnology or Industrial Chemistry)
• 5 - 8 years experience in biopharmaceutical process engineering, specifically in the design, construction, and startup of relevant facilities.
• Demonstrated ability to lead and influence teams in a matrix team environment.
• Excellent communication, presentation, and organizational skills.
• In-depth understanding of process engineering and technologies specific to bulk vaccine or biologics processing facilities.
• Knowledge and experience in applying single-use technologies in biopharmaceutical manufacturing.
• Familiarity with DCS/PLC process control platforms and industry SDLC methodologies such as Delta V.
• Proven ability to coordinate large-scale projects and ensure they are completed on time and within budget.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ie

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