Operation Engineer

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).