About the Role:
We are seeking an experienced CQV (Commissioning, Qualification & Validation) Consultant to support Factory Acceptance Testing (FAT) and commissioning for a key project. The successful candidate will play a critical role in ensuring that equipment and systems meet regulatory and operational requirements before site installation.
Key Responsibilities:
- Lead and execute Factory Acceptance Testing (FAT) for equipment at vendor sites, ensuring compliance with user requirements and specifications.
- Develop and review FAT protocols, test scripts, and reports, ensuring thorough documentation and adherence to GMP guidelines.
- Identify, document, and resolve deviations or non-conformances encountered during testing.
- Coordinate with vendors, engineering teams, and project stakeholders to facilitate smooth execution of commissioning activities.
- Oversee commissioning activities on-site, ensuring proper installation, start-up, and operational verification of equipment.
- Support Site Acceptance Testing (SAT), IQ/OQ/PQ execution, and system handover as required.
- Ensure compliance with regulatory requirements (FDA, EMA, GMP, GAMP5) and internal quality standards.
- Provide technical troubleshooting and resolution for commissioning-related challenges.
- Maintain detailed records of validation and commissioning activities for audit readiness.
Key Requirements:
- 5+ years of CQV experience in the pharmaceutical, biotech, or life sciences industries.
- Strong expertise in FAT execution, commissioning, and validation of process equipment, utilities, or automation systems.
- Familiarity with GMP, GAMP5, FDA, and EMA regulatory guidelines.
- Hands-on experience with IQ/OQ/PQ protocols and validation lifecycle documentation.
- Strong problem-solving skills with the ability to work independently and in a team environment.
- Excellent communication and stakeholder management skills.
- Willingness to travel for FAT execution at vendor sites.
Preferred Qualifications:
- Degree in Engineering, Life Sciences, or a related technical field.
- Experience with fill-finish, bioprocess, or sterile manufacturing equipment is a plus.
- Previous experience supporting large-scale capital projects.
