- Company Name
- Optimus Search
- Job Title
- Manufacturing Qualification Specialist
- Job Description
-
**Job title**
Manufacturing Qualification Specialist
**Role Summary**
Execute and lead the qualification of upstream and downstream manufacturing equipment for a biopharmaceutical facility, ensuring compliance with GMP, GDP, and data integrity standards. Manage IQ/OQ/PQ activities across single‑use and stainless‑steel assets, coordinate with suppliers, resolve deviations, and produce accurate qualification documentation.
**Expectations**
- Complete a 6‑month freelance contract focused on qualification execution.
- Deliver all qualification milestones on schedule while managing multiple systems simultaneously.
- Demonstrate strong stakeholder engagement with QA, Engineering, Manufacturing, and Automation teams.
**Key Responsibilities**
- Design, execute, and validate IQ/OQ/PQ protocols for biomanufacturing and process equipment (USP/DSP).
- Lead qualification activities for single‑use systems, bioreactors, mixers, and automation platforms (e.g., DeltaV).
- Identify, analyze, and remediate discrepancies, deviations, and CAPAs during qualification.
- Collaborate with equipment suppliers for FAT/SAT and IOQ testing.
- Author, review, and approve qualification protocols, test scripts, reports, and change controls.
- Ensure full adherence to GMP, GDP, and data integrity guidelines.
- Provide status reports to the CQV Lead and project management.
**Required Skills**
- 10+ years in pharmaceutical/biotech manufacturing qualification (CQV).
- Proven experience with USP and DSP equipment and processes.
- Expertise in IQ/OQ/PQ execution, deviation/CAPA management, and documentation review.
- Familiarity with DeltaV automation and CSV basics.
- Strong analytical, communication, and stakeholder‑engagement abilities.
- Fluency in English; French a plus.
**Required Education & Certifications**
- Bachelor’s or Master’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field.
- GMP and CQV training; certifications in Quality Assurance, CAPA, or related disciplines are advantageous.