Senior Process Engineer
Our client is a leading biotech company that develops, manufactures, and delivers vaccines and therapeutics worldwide for various world health threats. The client strives to eliminate emerging threats from the core, to empower healthy lives. Being in the Greater Boston area, at a brand-new site makes it an ideal location.
Responsibilities Include:
- Oversee and execute capital projects, process improvement endeavors and project execution for a wide range of product values.
- Writing technical equipment life cycle documents.
- Preparation of design packages, RFP's, design review, vendor selection, change controls.
- Oversight & support for CQV team for process qualification and validation.
- Manage process system deviations.
- Programming, maintenance, and troubleshooting: Monitoring systems & logic controllers.
- Create engineering drawings and layouts.
Required:
- BS, MS or PhD in a STEM field.
- Relevant job experience of 7+ years (dependent on degree level).
- Understanding of MSAT activities; tech transfer, strategy implementation, process development and improvement.
- Knowledge of GMP, commissioning and qualification.
- Knowledge of SIP, CIP, Downstream Ops, formulation, bulk manufacturing.
- Ability to manage multiple high-level priorities in a dynamic environment.
- Create layouts, P&ID's, PFD's, EDM program.
- Knowledge of PFD's, PID's, URS's, EDS's (engineering documentation).
- Programming experience in PLC's & HMI's.
