About the Role:
Join our dynamic Quality & Validation team at Masuu Global Solutions! We are looking for a skilled Validation Engineer with 6-8 years of experience in OSD & Injectable pharmaceutical equipment qualification and process validation.
Key Responsibilities:
Equipment Qualification:
- ‘Experienced in AutoCAD drafting’
- Prepare and review URS, functional specs, and design documents with engineering & vendors
- Develop & execute DQ/IQ/OQ/PQ protocols for manufacturing, packaging, utilities & support systems
- Qualify OSD equipment (granulators, blenders, tablet compressors, coating pans) and Injectable equipment (autoclaves, vial washers, filling machines, lyophilizers)
- Supervise calibration & qualification of utilities: HVAC, compressed air, nitrogen, WFI, RO, PW
Validation:
- Design and conduct process and cleaning validation (CIP/SIP/manual/automated)
- Support technology transfer, scale-up, and commercial manufacturing phases
- Prepare & execute computer system validations
- Provide documentation support during regulatory audits & inspections
- Apply knowledge of cGMP, 21 CFR Part 11, GAMP 5, and risk-based qualification
- Collaborate effectively with cross-functional teams to ensure compliance
What We’re Looking For:
- B. Pharm / M. Pharm / B. Tech in Mechanical / Instrumentation / Chemical Engineering
- 6-8 years experience in validation for OSD & Injectable pharma environments
- Strong knowledge of pharmaceutical manufacturing processes and validation tools
- Excellent documentation, analytical, coordination & communication skills