[ref. l07813902] CQV Specialist / Senior Validation Engineer 2 - 5381

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

Senior CQV Engineer Responsibilities:

• Prepare, author, and execute commissioning and qualification (CQV) documentation for modifications to the gas distribution system supporting QC Environmental Monitoring (EM)
• Develop and execute high-quality protocols (IQ, OQ, PQ) and ensure detailed documentation for regulatory compliance
• Coordinate gas sampling activities and validate system modifications in alignment with cGMP standards
• Collaborate with cross-functional teams, including QC and Quality Assurance, to ensure successful execution and validation
• Maintain focus on documentation quality and accuracy throughout the project lifecycle
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• 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
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts

• Position requires onsite work execution in Warren, NJ
• Bachelor’s degree in Engineering, Life Sciences, or a related field preferred
• Knowledge of QC EM processes, gas distribution systems, and sampling validation requirements
• 5+ years of experience in CQV activities, with demonstrated expertise in gas system validation and documentation
• Strong skills in document authorship, including protocol creation, execution summaries, and final reports
• Proven ability to work in cGMP-regulated environments and deliver results on time
• Excellent writing, organizational, and collaboration skills
• General understanding of capital equipment implementation and process knowledge
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

Benefits

• 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

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.

• Verista is an equal opportunity employer.