About the Company
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT.
Position: Technology Transfer / Equipment Implementation Engineer
Location: Spokane, WA
Duration: Long Term
Job Overview
We are seeking an experienced Technology Transfer / Equipment Implementation Engineer to support technology transfer, new product introduction (NPI), equipment implementation, and qualification activities within a pharmaceutical manufacturing environment.
Key Responsibilities
- Support technology transfer and new product introduction (NPI) activities.
- Review technology transfer documentation and support manufacturing readiness.
- Translate process requirements, CPPs, and CQAs into equipment and manufacturing requirements.
- Support process implementation, engineering runs, PPQ, and manufacturing startup.
- Develop URS, equipment specifications, and technical requirements.
- Coordinate equipment design reviews, vendor activities, procurement, installation, and startup.
- Support equipment commissioning, FAT, SAT, IQ, OQ, and PQ activities.
- Support equipment troubleshooting, qualification strategy, and GMP readiness.
- Manage deviations, CAPAs, change controls, and root cause investigations.
- Collaborate with Engineering, MSAT, Manufacturing, Quality, Validation, and vendors.
Required Qualifications
- Bachelor's degree in Engineering or a closely related technical field.
- 7+ years of experience in pharmaceutical, biotech, biologics, or sterile manufacturing environments preferred.
- Direct experience in technology transfer and/or new product introduction.
- Experience with CPPs, CQAs, process development, process validation, and manufacturing scale-up.
- Experience developing URS and equipment specifications.
- Experience with equipment design reviews and vendor coordination.
- Experience with FAT, SAT, IQ, OQ, and PQ activities.
- Experience with deviations, CAPAs, and change controls.
- Strong communication, troubleshooting, and cross-functional collaboration skills.
- Sterile manufacturing, fill-finish, aseptic processing, CIP/SIP, or capital project implementation experience is a plus.
- Experience with TrackWise or similar quality systems is preferred.
How to Apply
Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.