Currently EPM is supporting a Global Life Sciences Company which is providing new solutions to transform human health. The clients customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. Working on challenges that truly matter with people that care for each other, our customers, and their patients with associates across 40 countries.
Essential Job Functions:
*Write and conduct computer/equipment system/software validations (IOPQ) for manufacturing
and QC processes/equipment.
*Generate and sustain Verification/Validation protocols and related technical documents to
support the transfer of processes into QC and Manufacturing.
*Write equipment risk assessments (critical component assessments), validation plans and
qualification reports.
*CNC & CMM programming
*Manage associated qualification deviations & CAPAs, including opening, resolution, and closure
*Design and perform process characterization studies and experiments using statistical methods
to develop new and/or improve existing assembly processes
*Conduct root cause analysis on product quality issues, identify trends, and communicate with
other functional departments for resolution.
*Develop, establish, and optimize quality inspection methods, test methods, and product
specifications by working closed to R&D department.
*Define frequency for the verification of validated equipment (preventive maintenance and/or
calibration).
*Partner with cross functional teams to evaluate design and processes at concept phase and
define manufacturing processes.
*Develop new and/or improved processes for parts through the application of theoretical and
practical engineering.
*Act as Subject Matter Expert for the validation/qualification process for QC and Manufacturing.
*Perform additional duties as required
Education:
*Master's degree in Mechanical, Biomedical Devices, Plastics Engineering, or equivalent
experience with minimum of 5 years related experience in pharmaceutical or medical device
*Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
*Quality Management System experience
*Self-starting, motivated individual with proven track record of learning new skills to achieve
results.
*Strong knowledge of manufacturing and laboratory systems
*Experience in process development, acceptance testing and qualification of equipment.
*Analytical spirit and data driven
*English, French language
*Project management experience
Benefits:
*Benefits + Bonus
*Attractive performance
*Development opportunities.
