Lead CQV Engineer/Analyst
Description For Lead CQV Engineer/Analyst
Verista is seeking a Lead CQV Engineer/Analyst to join their team. This role involves leading Commissioning, Qualification, and Validation (CQV) efforts for facilities, utilities, and production equipment in the pharmaceutical industry. Key responsibilities include developing and executing IQ/OQ/PQ protocols, conducting risk assessments, ensuring regulatory compliance, and collaborating with cross-functional teams. The ideal candidate will have 10+ years of experience in validating production equipment, strong knowledge of GMP and regulatory requirements, and excellent project management skills. This position offers a competitive salary range of $80,465 - $129,826 and a comprehensive benefits package including medical insurance, 401(k) with employer matching, paid time off, and tuition reimbursement. Verista provides innovative solutions in the life sciences industry, empowering growth and innovation to help solve pressing healthcare challenges. The company culture values empowerment, client success, integrity, inclusivity, and continuous learning.
Responsibilities For Lead CQV Engineer/Analyst
- Lead CQV efforts for facilities and utilities, including HVAC, water systems, and building automation
- Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems
- Collaborate with engineering and project teams to align validation activities with construction schedules
- Ensure all validation documentation complies with regulatory standards (FDA, cGMP)
- Conduct risk assessments and develop mitigation strategies for potential compliance issues
- Develop and execute commissioning, qualification, and validation protocols for production equipment
- Coordinate with equipment vendors for FAT/SAT activities and ensure integration into facility systems
- Oversee equipment calibration, performance verification, and documentation
- Lead risk assessments to identify and mitigate potential equipment compliance risks
- Provide cross-functional support for other CQV efforts within the project
Requirements For Lead CQV Engineer/Analyst
- Must be willing to work onsite in New Brunswick, NJ
- Bachelor's degree in Engineering, Life Sciences, or related field
- 10+ years of experience in validating production equipment in pharmaceutical environments
- Expertise in isolators, bioreactors, fume hoods, and other lab equipment
- Strong knowledge of regulatory requirements and risk-based validation approaches
- Excellent project management and problem-solving skills
- Excellent documentation and communication skills
- Experience in qualifying 'first in kind' equipment
- Experience with Robotic arms and processing
- Proficiency using PC and Microsoft Office tools
- Strong attention to detail
- GMP and Good Documentation Practice
- Experience in GMP regulated environment
Benefits For Lead CQV Engineer/Analyst
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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