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