Equipment Engineer- I
Everyone in the company is grounded by one goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
It is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and haematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
We are seeking a highly motivated individual to join us as an Equipment Engineer supporting our manufacturing facility. In this role, you will be a key contributor to the building of a new manufacturing organization.
• Equipment Engineer supporting the start-up, licensure, and routine operation of a fully automated cell therapy manufacturing facility
• Evolving Subject Matter Expert for cell therapy process equipment, clean rooms, and clean utilities
• Implement Reliability Engineering focused on the following: Loss Elimination and Efficiency Improvement, Risk Management, and Asset Life Cycle Management
• Implement site reliability program. Pull metrics and partner with engineering team for implementation of improvement initiatives.
• Plan and implement reliability methods that reduce losses and reduce maintenance and production costs
• Move the site away from preventative to a predictive maintenance strategy
• Responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans.
• Evaluate and implement Risk Management, utilizing tools such as FMEA, Fault Trees, RCA, PHA, Reliability modeling etc…
• Support investigation and identify root cause for critical equipment and determine CAPA for manufacturing
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing including optimizing single use components for system closure
• Work with vendors and process development to define equipment requirements
• Interact with the automation team to develop fully automate the MFG process with integration to Electronic Batch Records
• Assist in design, procurement, C&Q, and PPQ batches to license the facility
• Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing)
• Executes change control and change management including cost and change justification during startup and C&Q activities
• Run Capital Projects supporting increased infrastructure and manufacturing capacity
• May coordinate contract personnel through completion of assignments
• MS Degree and 5+ years’ experience in cGMP commercial manufacturing and regulatory requirements OR
• BS Degree and 7+ years’ experience in cGMP commercial manufacturing and regulatory requirements OR
• High School Degree and 11+ years’ experience in cGMP commercial manufacturing and regulatory requirements
• Understanding of basic engineering principles
• Degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or Mechanical Engineering
• Experience as a Reliability Engineer
• Experience with clean rooms, HVAC, ISO standards, and utilities supporting cGMP manufacturing
• Experience implementing systems to address common reliability problems with a track record of success in solving the underlying problems
• Experience with reliability engineering tools and best practices
• Demonstrated troubleshooting and problem-solving skills with GMP process equipment
• Data trending and analysis for GMP process equipment
• Cell culture or aseptic processing experience
• Previous experience with cell therapy products is a plus
• Understands and employs principles and concepts of Lean Six Sigma to improve process capability
• Ability to generate, read and interpret drawings such as PFDs, floor plans, P&IDs and electrical schematics
• Working knowledge of instrumentation and controls, as well as PLCs and DCS
• Excellent interpersonal, verbal and written communication skills.
• Self-motivated and willing to accept responsibilities outside of initial job description.
• Well-developed computer skills.
Does this sound like you? If so, please apply today!