Job Description

Position Summary:

Our client is seeking an experienced Commissioning and Qualifications (C&Q) Specialist to support the execution of commissioning and qualification activities for GMP-compliant systems. This role is critical in ensuring the delivery of validated systems that meet regulatory requirements, support product quality, and align with our client's commitment to animal health. The ideal candidate will have a strong background in computer system validation (CSV) , SOP development , and project execution within regulated environments .

Key Responsibilities:

• Execute and manage commissioning and qualification (C&Q) activities in accordance with GxP, FDA, EMA, and other applicable regulatory standards.
• Support the development and execution of lifecycle documentation including URS, FS, DS, DQ, IQ, OQ, and PQ protocols.
• Lead or assist in Computer System Validation (CSV) efforts, ensuring compliance with 21 CFR Part 11 and Annex 11.
• Draft, revise, and maintain Standard Operating Procedures (SOPs) , protocols, and technical reports.
• Coordinate with engineering, quality, IT, and operations teams to ensure timely and successful project execution.
• Perform risk assessments and impact assessments to determine validation strategy and scope.
• Support audits, inspections, and CAPA closure related to validation and qualification activities.
• Apply knowledge of GAMP 5, ASTM E2500, and risk-based validation approaches.
• Contribute to continuous improvement initiatives within the validation and qualification space.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• Minimum of 5 years of experience in C&Q, CSV, and validation within a GMP-regulated pharmaceutical, biotech, or life sciences environment.
• In-depth knowledge of regulatory requirements, validation lifecycle, and industry best practices.
• Demonstrated experience in developing and executing validation protocols and SOPs .
• Strong understanding of automated systems, IT infrastructure, and data integrity principles.
• Excellent communication, technical writing, and project management skills.
• Ability to work independently and collaboratively in a cross-functional team environment.

Preferred Qualifications:

• Experience in animal health or veterinary pharmaceutical industry.
• Familiarity with global validation standards.
• Lean or Six Sigma certification is a plus.

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