Job Title: CQV Engineer – Pharmaceutical Filling Lines

Experience Level: Senior (8+ years)

Job Overview:

The ideal candidate will have at least 8 years of experience working in pharmaceutical or biotech manufacturing environments, with a strong focus on filling lines. This position plays a critical role in ensuring that our filling line equipment and processes meet regulatory standards, ensuring the highest level of quality and compliance in the production of sterile drug products.

Key Responsibilities:

• Commissioning & Qualification:

  • Lead commissioning and qualification activities (IQ/OQ/PQ) for new and existing filling lines and associated equipment (e.g., isolators, autoclaves, sterile filling machines).
  • Develop and execute commissioning, qualification, and validation protocols for process equipment, utilities, and cleanrooms.
  • Perform risk assessments, FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and vendor audits.

• Validation:

  • Oversee the validation of automated and manual filling systems, ensuring compliance with FDA, EMA, and GMP regulations.
  • Execute process validation, cleaning validation, and sterilization validation activities for filling lines.
  • Prepare and review validation master plans, protocols, and reports for filling processes.
  • Ensure continuous validation in response to process improvements or changes in regulatory guidelines.

• Technical Support:

  • Provide technical expertise and troubleshooting support for filling line systems during CQV activities.
  • Collaborate with engineering, production, quality assurance, and other departments to ensure smooth project execution.
  • Support technology transfer and new product introductions on filling lines.

• Regulatory Compliance:

  • Ensure all CQV activities are compliant with local and international regulatory guidelines (e.g., cGMP, FDA, EU, ICH).
  • Prepare for and participate in internal and external audits and regulatory inspections.
  • Maintain up-to-date knowledge of industry trends, standards, and regulatory updates related to filling lines and CQV practices.

• Documentation:

  • Author, review, and approve qualification and validation documentation, including protocols, reports, and deviation resolutions.
  • Ensure accurate documentation and reporting of all CQV activities.

Qualifications & Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of 8 years of experience in CQV activities within a pharmaceutical or biotech manufacturing environment.
• Proven experience with pharmaceutical filling lines, sterile processing, and related equipment.
• Strong knowledge of FDA, EMA, and global regulatory standards for sterile drug manufacturing.
• Experience with cleanroom and utility systems qualification (HVAC, WFI, compressed air, etc.).
• Proficiency with validation methodologies, such as risk-based approaches, and technical writing of protocols/reports.
• Strong problem-solving, project management, and communication skills.
• Ability to work in a team-oriented environment and collaborate effectively across departments.

Preferred Skills:

• Knowledge of automation systems (SCADA, PLC, MES) used in filling lines.
• Experience with lyophilization, syringes, vials, or other advanced aseptic filling technologies.
• Familiarity with data integrity requirements (21 CFR Part 11, Annex 11).

Why Join Us?

• Opportunity to work in a cutting-edge pharmaceutical manufacturing facility.
• Be a part of a dynamic and fast-growing team that is shaping the future of drug production.
• Competitive salary, benefits, and opportunities for career growth.

If you meet the above qualifications and are passionate about ensuring the highest standards in pharmaceutical manufacturing

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

Wesley Cann