Senior Process Engineer

4 weeks ago

Cork, Cork, Ireland The Aphex Group Full time

Senior Process Engineer

Purpose

Provide process engineering services in support of the design, commissioning, and qualification of a significant expansion to an existing bulk vaccine processing facility. The jobholder works with the Process Engineering Team as a client owner representative to deliver project objectives.

Responsibilities
  1. Support the Process Lead in implementing a process design based on the scope of process requirements outlined in the project scope of work.
  2. Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
  3. Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
  4. Monitor progress of process suite team milestones and provide status reports to project tiers and stakeholders.
  5. Oversee C&Q progression by a partner firm.
  6. Ensure site engineering standards, procedures, and practices are followed.
  7. Support the C&Q Lead in coordinating and leading C&Q field execution when necessary.
  8. Develop and review system lifecycle documents including criticality and risk assessments, FAT documentation, and C&Q documentation.
  9. Manage installation, start-up, and testing of process systems through OQ completion, ensuring system readiness for PQ and PPQ stages.
  10. Liaise with stakeholders, equipment vendors, business partners, and SMEs across sites within the manufacturing network to support the project.
Qualifications
  1. B.Sc. or M.Sc./M.Eng. degree in Chemical or Biochemical Engineering or an equivalent discipline, such as Biotechnology or Industrial Chemistry, with fundamental knowledge of chemical/biochemical engineering as applied to biotechnology/bioprocessing.
  2. At least 8 years of post-academic process engineering experience in biopharmaceutical processing, including design, construction, and startup environments.
  3. Proven ability to lead and influence teams within a matrix organization.
  4. Excellent communication, presentation, and organizational skills.
  5. Deep understanding of process engineering and technologies relevant to unit process and utility operations for bulk vaccine/biologics facilities.
  6. Knowledge of single-use technologies.
  7. Experience with DCS/PLC process control platforms and SDLC methodologies such as Delta V.
Additional Details
  • Seniority level: Mid-Senior level
  • Employment type: Contract
  • Industry: Pharmaceutical Manufacturing

Note: This job posting is active. No indication of expiration was found.

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