Lead CQV Engineer/Analyst - 5071

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Lead CQV Engineer/Analyst Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Understanding validation documents, URS, IQ, OQ, PQ
• 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).
• Validation master planning
• Conduct risk assessments and develop mitigation strategies for potential compliance issues.
• Provide cross-functional support and expertise to other CQV activities as needed.
• 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

• 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.
• Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification
• Experience in qualifying "first in kind" equipment
• Experience with Robotic arms and processing
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• 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 (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

For more information about our company, please visit us at Verista.com

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

$80,465 - $129,826

*Verista is an equal opportunity employer.