What are the responsibilities and job description for the CQV Lead (Pharma/Biotech) position at SPADTEK SOLUTIONS LLC?
Job Description:
We are seeking a highly experienced CQV Lead to drive Commissioning, Qualification, and Validation activities for large-scale capital projects within a GMP-regulated pharmaceutical/biotech environment. The ideal candidate will be responsible for leading CQV strategy, execution, and ensuring compliance with regulatory standards.
Key Responsibilities:
- Lead CQV strategy and execution for capital projects (greenfield/brownfield)
- Develop and review validation lifecycle documents (URS, DQ, FAT, SAT, IQ, OQ, PQ)
- Oversee commissioning and qualification of process equipment, clean utilities, and facilities
- Ensure compliance with cGMP, FDA, and global regulatory requirements
- Collaborate with Engineering, QA, Manufacturing, and Project teams
- Manage CQV timelines, deliverables, and resources
- Support regulatory inspections and audits (FDA, EMA, etc.)
- Identify risks and implement mitigation strategies
- Mentor and guide junior CQV engineers
Required Qualifications:
- 15 years of CQV experience in Pharma/Biotech industry
- Strong experience with large-scale capital projects
- Hands-on validation experience (equipment, utilities, facilities)
- In-depth knowledge of cGMP, FDA regulations, and validation lifecycle
- Proven leadership and team management skills
- Strong communication and documentation skills
Preferred Qualifications:
- Bachelor’s/Master’s degree in Engineering (Chemical, Mechanical, or related)
- Experience in cleanroom validation, aseptic processing, or biologics manufacturing
- Familiarity with HVAC, WFI, CIP/SIP systems and process automation
Pay: $45.00 - $50.00 per hour
Work Location: In person
Salary : $45 - $50