Process Validation Engineering Co-Op
Core
Support process validation activities across the biologics manufacturing lifecycle, including process design, qualification, and continued verification.
Role type
Process Validation Engineering Co-op
Builds
Validated biologics manufacturing processes for CDMO services
Domain
Life sciences / Biotechnology / Biologics manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Chemical/Bioprocess/Biomedical/Biological Systems Engineering/Biotechnology background, technical data interpretation, Microsoft Excel proficiency
Preferred skills
GMP-regulated environment exposure, statistical analysis (JMP/Minitab), cellular process steps under GLPs
Responsibilities
Support development, execution, and reporting of process validation activities; Participate in ancillary validation studies (APS/media fills, PQ, cleaning validation, CCIT, hold-time studies); Collaborate with cross-functional teams (Manufacturing, MSAT, QA, QC, Engineering, Regulatory Affairs)
Seniority
Co-op / Intern