Job description:
Primary Objective / Purpose
To support manufacturing operations from commissioning through PPQ, providing expertise in DeltaV and MES, and ensuring operational readiness for media/buffer preparation and downstream purification processes.
Key Responsibilities
- "• Support the Operations team throughout the commissioning and Process Performance Qualification (PPQ) phases.
- • Provide operational expertise for recipe creation, as well as batch record design and review.
- • Oversee operations related to Media / Buffer preparation OR Extraction / Purification (including Grinder, Centrifuge, UF, Chrom, and Sterile filtration).
- • Execute qualification protocols for loose equipment (e.g., spectrophotometers, incubators, fridges, and freezers)."
Key Deliverables
- "• Designed and reviewed batch records and recipes.
- • Completed loose equipment qualification protocols and reports.
- • Operations readiness and support documentation for commissioning to PPQ phases."
Required Skills & Qualifications
- "• 5 to 8 years of experience in the pharmaceutical manufacturing industry.
- • Familiarity with DeltaV and Manufacturing Execution Systems (MES).
- • Strong background in manufacturing operations.
- • Note: This is a 1.5 to 2-year contract role (starting with a 1-year contract with the possibility of extension)."
Job Type: Full-time
Work Location: In person
