Technical Source is looking for an experienced CQV Engineer with 4-8 years of expertise in commissioning, qualification, and validation within a pharmaceutical manufacturing environment. This role will focus on ensuring that all systems, equipment, and processes meet regulatory standards and are fully operational. The ideal candidate will have a solid background in CQV, strong analytical skills, and a commitment to quality and compliance.
Key responsibilities:
- Oversee and perform commissioning and qualification activities for equipment, utilities, and processes to ensure they meet FDA, GMP, and other regulatory standards
- Develop, execute, and review validation protocols for systems and processes, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Prepare detailed CQV documentation, including validation protocols, reports, and standard operating procedures (SOPs) in compliance with regulatory standards
- Coordinate with Project Managers and cross-functional teams to align CQV activities with project timelines, milestones, and objectives
Qualifications:
- 4-8 years of experience in CQV roles within the pharmaceutical or biotech manufacturing industry
- In-depth knowledge of CQV principles, regulatory requirements (e.g., FDA, GMP), and hands-on experience with equipment and process qualification
- Proficiency in data analysis, risk assessment, and root cause analysis
- Strong written and verbal communication skills, with an ability to collaborate effectively across departments
