Process Engineer MSAT/CQV - Biologics/Pharmaceuticals
Position Summary - MSAT/CQV Process Engineer
Location: Minneapolis - HYBRID 50%-80% onsite
We are seeking an experienced MSAT/CQV Process Engineer to support technology transfer and CQV activities within a pharmaceutical/biologics manufacturing environment. This role will focus on startup execution, process knowledge transfer, and ensuring successful scale-up and operational readiness across upstream and downstream processes.
This resource will join during the late design phase and support transition into execution, with a strong focus on CQV (commissioning, qualification, and validation) activities as systems move toward operational readiness. As the project progresses, the role will also assist with early construction ramp-up and field execution support.
*See equipment requirements below.
Required Experience
- Minimum of 10+ years of experience as a Process Engineer with Tech Transfer and CQV experience
- Background within pharmaceutical or biologics manufacturing environments
- Demonstrated experience supporting startup-related tech transfer activities
- Hands-on experience with both upstream and downstream processing
- Working knowledge and experience with CIP (Clean-in-Place) systems
- Direct involvement in CQV (Commissioning, Qualification, and Validation) activities and equipment
Preferred Experience
- Experience supporting startup or facility build/expansion projects with end-to-end tech transfer involvement highly desired
- Proven track record of contributing to technology transfer initiatives within pharmaceutical or biologics organizations
Detailed Design Responsibiliities:
- Preferred ability to be onsite 50% - 1st 6 months
- Familiarity with mAB production unit ops (Bioreactor, Chromatography, UFDF, etc)
- Knowledge of process equipment (SS piping, valves, Transfer Panels, etc)
- Familiarity with a Mass Balance
- Previous design work preferred
- Familiar with ENG design deliverables (URS, Functional Specification, etc)
Commissioning/Start Up Responsibilities:
- Onsite required >80%
- Familiarity with mAB production unit ops (Bioreactor, Chromatography, UFDF, etc)
- Knowledge of process equipment (SS piping, valves, Transfer Panels, etc)
- Experience troubleshooting/supporting a production process
- Previous start up support preferred
- Familiar with C&Q activities (FAT/SAT, Qualification, water batching, etc)
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
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