Job Description
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.
- Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
- 2-6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
- Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.
- Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
- Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
- Collaborate with Manufacturing, QA, Engineering, and R&D teams.
- Analyze validation data, investigate deviations, and support CAPA implementation.
- Prepare validation reports and support internal/external audits.
- Review and support change controls for validated systems.
Skills
Biomedicineunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Chemical Engineeringunmatched
Code of Federal Regulationsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Analysisunmatched
External Auditunmatched
FDA Requirementsunmatched
ICH Regulationsunmatched
Internal Auditunmatched
Manufacturingunmatched
Process Validationunmatched
Quality Assuranceunmatched
Reporting Skillsunmatched
Research & Development (R&D)unmatched
System Validationunmatched
Temperature Mappingunmatched
Validation Planunmatched
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