Job Specification: Senior Process Engineer (Candidates must be eligible to work in Ireland without requiring visa sponsorship)
Department: Technology Centre, Global Engineering Solutions (GES)
Position Reports to: Director Engineering
Role Summary: The Senior Process Engineer will support the design, commissioning, and qualification of a significant expansion to an existing bulk vaccine processing facility.
This role involves working with the Process Engineering Team to deliver project objectives.
KEY FOCUS: Single Use Technologies: The role requires expertise in single-use technologies, including Single Use Mixers and Single Use UFDF skids.
Job Responsibilities: Process Design and Implementation: Support the GES Process Lead in implementing a process design based on project requirements.
Lead cross-functional project teams to ensure stakeholder inputs are reflected in commissioning and qualification (C&Q) deliverables.
Project Management: Monitor progress of process suite team milestones and provide status reports.
Oversee C&Q progression by a partner firm.
Ensure compliance with the company's site engineering standards.
Documentation and Coordination: Develop and review system lifecycle documents, including criticality and risk assessments, FAT documentation, and C&Q documentation.
Manage installation, start-up, and testing of process systems through operational qualification (OQ) completion.
Ensure systems' post-OQ readiness.
Stakeholder Engagement: Liaise with stakeholders, equipment vendors, business partners, and SMEs within the company's Manufacturing Network.
Project Engineering Duties: Prepare project-related deliverables such as schedules, work plans, and equipment cost tracking.
Coordinate project activities between stakeholders.
Education/Experience Requirements: Minimum Qualification: B.Sc.
or M.Sc./M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.
Experience: Minimum of 8 years post-academic process engineering experience in biopharmaceutical processing design, construction, and start-up.
Skills: Demonstrated ability to lead and influence teams.
Excellent communication, presentation, and organizational skills.
In-depth understanding of process engineering and technologies for bulk vaccine/biologics processing.
Knowledge of Single Use Technologies is essential.
Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V. Additional Information: Onsite Role: This position requires working onsite with some travel to EU/US locations.
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