Validation Engineer III - OSD/Packaging/AVI
Core
Lead manufacturing process validation activities for Oral Solid Dose (OSD) continuous manufacturing and pharmaceutical packaging operations, including support for Automated Visual Inspection (AVI).
Role type
Senior IC validation engineer (pharmaceutical manufacturing)
Builds
Validated manufacturing processes and packaging systems for commercial pharmaceutical products
Domain
Pharmaceutical manufacturing / Continuous manufacturing / Regulatory compliance (via careerplan.io/jobs/R-01358684-validation-engineer-iii-osdpackagingavi-at-thermofisher)
Required skills
Validation protocol development and execution (IQ/OQ/PQ), GMP compliance, technical writing, data analysis, cross-functional collaboration, regulatory inspection support
Preferred skills
OSD continuous manufacturing, packaging process validation, AVI validation, sterile packaging validation, Lean Manufacturing
Technologies
Microsoft Office, validation documentation systems
Responsibilities
Develop, execute, and document validation protocols; Perform packaging process validation; Analyze validation data and prepare technical reports; Support cleaning validation activities; Collaborate with Manufacturing, Engineering, Quality, and Technical Operations teams; Participate in peer review of validation documentation; Support internal, customer, and regulatory audits
Seniority
Senior, hands-on IC