Note: This is a 2 year contract!
Required Skills & Experience
· Bachelor’s degree in engineering (Mechanical, Electrical, Automation, Mechatronics, or related)
· 5+ years delivering complex equipment in regulated manufacturing environments (medical device, pharma, aerospace, etc)
· Proven experience managing external vendors or system integrators
· Strong understanding of GMP, design control, and equipment qualification
· Demonstrate experience working with bespoke, non-standard automation equipment, ideally in medical device and/or pharma environment.
Nice to Have Skills & Experience
· Cell therapy processing
· automation/controls integration and robotics
· startup/stabilization support
· Working for 3rd party automation, CDMO, equipment or technology vendors in a design/automation industries
Design for Manufacture and Design for automation DFM/DFA experience highly desirable
Job Description
We are seeking a hands‑on, technically strong engineer to lead vendor‑led development of cell therapy processing equipment for GMP manufacturing. This role serves as the primary technical owner and interface between internal cross‑functional teams and external equipment suppliers to deliver robust, compliant, and scalable solutions.
The successful candidate will translate process needs into clear requirements, guide design decisions, manage technical risk, and drive execution through design, build, FAT/SAT, qualification, and handoff to operations. A strong focus on documentation quality, data integrity, and inspection readiness is essential.
Key responsibilities include:
· Technical ownership of vendor‑led equipment development, including scope alignment, interfaces, and acceptance criteria
· Leadership of design reviews, technical governance, issue resolution, and change control
· Authoring and owning URS/FRS inputs with full traceability to verification and validation
· Oversight of FAT/SAT, commissioning, and qualification readiness in partnership with Quality and CQV
· Ensuring GMP compliance, data integrity, and controlled documentation across vendor deliverables
· Driving cross‑functional alignment and proactive risk management