What are the responsibilities and job description for the CQV Lead (Pharma/Biotech) position at Spadtek Solutions LLC?
Job Title: CQV Lead (Pharma/Biotech)
Location: Indiana (Onsite – Must be willing to relocate)
Experience: 15 Years
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