Sr. Engineer/ Manager, Process Development
The Sr. Engineer/ Manager is responsible for leading the engineering team for cGMP facilty and process equipment design, scale-up, specifications, installations, commissioning, and technical support. This position reports directly to the Director, Process Development and Production.
- Engineering oversight of cGMP facilities, utilities, and process equipment, including design, scale-up, specifications, installations, commissioning, and technical support
- Manage contractors and vendors related to new process equipment, utilities, and facilities
- Perform cost analysis to support new programs, scale-up proposals, and upgrades to existing systems
- Develop best practices, routines and innovative solutions to improve process and quality of output.
- Perform risk assessment, incident investigation and corrective actions
- Provide process documentation and operating instructions.
- Provide technical support to process development and clinical production teams
- Vision to guide a team in engineering requirements when developing a new production process.
- Develop engineering lab for custom fabrication of process equipment.
- Develop process for creation, part numbering and control of custom CAD drawings to define custom process equipment to be used for GMP manufacturing.
- Manage engineering project budgets and timelines
Technical Skills and Knowledge:
- Knowledge in design cGMP manufacturing facility
- Knowledge in FDA and ISO guidelines.
- Knowledge in computer system validation
- Knowledge in AutoCAD
- Knowledge in FMEA, risk analysis, process characterization
- ISPE certification is preferred.
- Bioprocess experience (bioreactor, chromatography) is preferred.
- Analytical thinker with interpersonal skills.
- Attention to details.
- Good technical writing skills
- Good communication skills
- Minimum of 10 years’ relevant industry experience
- B.E, M.E. or PhD in engineering
- Proven work experience in facility and process engineering
- Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
APPLY FOR THIS JOB
- Occasional (equipment selection, factor acceptance testing, conferences, etc.)