About the Role:

We are looking for a dedicated professional to support our clients' biomanufacturing operations. Your responsibilities will include conducting pre-commissioning inspections, performing in-depth tests, diagnosing process and equipment problems, generating thorough reports, working with teams from different departments, and consistently following pharmaceutical GMP and regulatory requirements.

Key Responsibilities:

Execution: Area Lead for team of process engineers. Plan and perform CQV activities for biomanufacturing facilities, utilities, and equipment.

Compliance: Ensure GMP, regulatory, and company standards in all work and documentation.

Coordination: Collaborate with engineering, project, quality, and vendors to complete CQV tasks.

Troubleshooting: Offer engineers expert assistance with resolving technical challenges encountered throughout the commissioning and qualification process.

Documentation: Prepare and review CQV lifecycle documents, including URS, DQ, IQ, OQ, and PQ.

Requirements:

• Diploma in a Science or Engineering related field, such as Biotechnology, Bioprocess Engineering, Biochemistry, Microbiology, Chemical Engineering.
• Minimum 10 years experience' in supporting bioprocessing operations such as fermentation, cell culture, or downstream processing.
• Knowledge of process automation and basic instrumentation.
• Excellent troubleshooting and communication skills
• Willing to accept a 1 year contract position