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
