- The Engineering Manager will provide mentorship and direction to staff on execution of the Qualification/Validation Lifecycle. Complete capital projects (new projects/project expansions/up-gradation of existing facilities) on time and within the approved budget.
- Develop a strong documentation package, involving form conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
- Preparation for various regulatory inspections/audits and active participation during audits, as needed.
- Develop Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, and safety analysis of biopharmaceutical processes.
- Provide conceptual, detailed design, project planning, and execution and qualification of biopharmaceutical facilities as per cGMP requirements.
- Process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, and CIP/SIP sequences, etc.
- Develop / review URS, Tendering, preparation of technical comparisons, DQ, FAT, recipient of equipment, SAT, commissioning, qualification and validation.
- Relocation provided, $100K-$120K.
- The Engineering Manager will have BS or MS degree with a engineering or chemistry major.
- At least 10 years of relevant experience in the pharmaceutical industry.
- Thorough understanding of aseptic filling unit operations and controls, as well as drug product process validation is necessary.
- Resource forecasting experience.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.