Biopharmaceutical Process Design Lead
2 weeks ago
Job Title: Senior Process Engineer
Company Overview:
Recruitment By Aphex Group is seeking a skilled Senior Process Engineer to provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.
Responsibilities:
- Support GES Process Lead to implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
- Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
- Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
- Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Oversee C&Q progression by a partner firm.
- Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
- Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
- Manage installation / start-up / testing of process systems through OQ completion.
- Interface with cross-functional team to ensure systems post-OQ (PQ, PPQ) readiness.
Qualifications:
- Bachelor's or Master's Degree in Chemical or Biochemical Engineering or equivalent discipline;
- Minimum of 8 years post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
- Demonstrated ability to lead / influence teams in a matrix team environment;
- Excellent communication/presentation/organizational skills;
- In-depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine/biologics processing facility.
- Knowledge on the application of single use technologies;
- Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.
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