Lead Process Engineer (CQV)

INTEGRIX SERVICES PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A firm in biomanufacturing is seeking a dedicated professional for a critical role in supporting clients' biomanufacturing operations. You will lead a team of process engineers, executing CQV activities and ensuring compliance with GMP regulations. The ideal candidate has a diploma in a science or engineering field and over 10 years of experience in bioprocessing operations like fermentation or cell culture. This role requires excellent troubleshooting skills and a willingness to accept a one-year contract.

Qualifications

• Minimum 10 years experience in supporting bioprocessing operations such as fermentation, cell culture, or downstream processing.
• Excellent troubleshooting and communication skills.
• Willing to accept a 1 year contract position.

Responsibilities

• Plan and perform CQV activities for biomanufacturing facilities, utilities, and equipment.
• Ensure GMP, regulatory, and company standards in all work and documentation.
• Collaborate with engineering, project, quality, and vendors to complete CQV tasks.

Skills

Troubleshooting and communication skills

Knowledge of process automation

Experience in bioprocessing operations

Education

Diploma in a Science or Engineering related field

Job description

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