Engineering Specialist - United States
Want to know company name or location? Company managed [?]
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as an Engineering Specialist.
- You will work with the Engineering and Manufacturing teams in supporting our efforts in this exciting new area of cancer immunotherapy.
- This role will be a hands-on resource reporting to the Sr. Manager Facilities & Engineering.
Responsibilities (include but are not limited to):
- Perform development and implementation of new equipment technologies
- Analyze equipment/processes and identify the areas that needs improvement.
- Provide guidance during planning, designing and development of projects.
- Write and review technical documentation (development reports, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing)
- Perform investigations and implement corrective actions
- Creation, execution of Test Protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations.
- Perform temperature mapping and other miscellaneous validation activities.
- Manage contractors performing equipment qualifications.
- Report status and progress of qualification activities or projects to the Leadership team.
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Develop technical specifications
- Execute projects as required
- Other duties as assigned
- BS or MS degree in Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or equivalent with 12+ years of experience. Engineering degree required.
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
- Cell culture experience
- Read and interpret drawings such as blueprints, PFDs, P&IDs, AutoCAD, PLC
- Working knowledge of scientific and engineering principles
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills and fluent with Microsoft office applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of the first 200 employees in this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.