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Biopharmaceutical Process Engineering Specialist
2 weeks ago
Biopharmaceutical Process Engineer
This role involves providing process engineering services for the design, commissioning, and qualification of a major expansion to an existing bulk vaccine processing facility.
The Process Engineer will act as a client-owner representative within the Process Engineering Team to ensure successful project execution.
Responsibilities:
- Support the Process Lead in implementing a Process Design based on defined project requirements.
- Lead cross-functional teams to ensure project and site stakeholder inputs are accurately captured and reflected in commissioning and qualification (C&Q) deliverables.
- Ensure clear communication and alignment among project stakeholders regarding key process suite activities and decisions.
- Track and monitor progress of process suite team milestones and provide status reports.
- Oversee C&Q execution performed by partner firms and ensure adherence to global engineering standards and best practices.
- Coordinate and support C&Q field execution, including development and review of system lifecycle documents.
Requirements:
- Minimum B.Sc. or M.Sc./M.Eng in Chemical, Biochemical Engineering, or equivalent discipline.
- Minimum of 8 years of post-academic experience in biopharmaceutical process engineering.
- Strong ability to lead and influence teams in a matrix organizational structure.
- Excellent communication, presentation, and organizational skills.
- In-depth understanding of process engineering and technologies relevant to bulk vaccine/biologics processing.
- Familiarity with DCS/PLC process control platforms and industry SDLC methodologies.
