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Verista · 21 hours ago

6085 - Senior CQV Engineer / Senior Validation Engineer

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

$70K/yr - $109K/yr

6+ years exp

Verista is a company that empowers growth and innovation within the life sciences industry. They are seeking a Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation activities for critical GMP utilities systems in pharmaceutical manufacturing operations.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Serve as the Utilities CQV Lead, owning CQV strategy, planning, and execution for assigned utility system

Lead and coordinate CQV activities across Engineering, Automation, Manufacturing, and Quality teams

Develop and manage CQV schedules, execution plans, and turnover packages for utilities systems

Lead CQV activities for the following critical utilities systems, including but not limited to: WFI (Water for Injection), Clean Steam, Glycol systems, CIP chemical distribution systems, Chilled Water, Process Air, NaOH distribution systems

Review of system design documentation, P&IDs, URSs, and specifications

Authoring, reviewing, and executing commissioning, IQ, OQ, and PQ protocols

Verification of system installation, operation, controls, alarms, and interlocks

Supporting startup, commissioning, and system performance verification activities

Ensure all CQV documentation complies with GMP, FDA, EMA, and ICH requirements

Author and review validation plans, protocols, reports, and traceability matrices

Participate in deviation investigations, change controls, and CAPAs related to utilities systems

Support internal audits and regulatory inspections related to utilities qualification

Perform and support risk assessments (e.g., FMEA, impact assessments) to define validation scope and critical parameters

Ensure utilities systems meet required quality attributes, reliability, and operational performance standards

Collaborate with Automation and Engineering teams to verify proper system integration and control strategies

Partner closely with Engineering, Automation, Quality Assurance, Manufacturing, and Facilities teams

Provide CQV guidance during project execution, system modifications, and upgrades

Mentor and support junior CQV engineers and validation resources as needed

Qualification

CQV leadershipGMP utilities systemsIQ/OQ/PQ lifecycleRegulatory complianceTechnical writingCross-functional collaborationExperience in biotechExperience in pharmaceuticalsExperience in cleanroomProblem-solvingCommunication skillsDetail-orientedMentoring

Required

Bachelor's degree in Engineering or a related technical discipline (or equivalent experience)

6+ years of CQV / Validation experience in a GMP manufacturing environment

Demonstrated experience leading CQV activities for utilities systems, including: WFI and Clean Steam, Process Air and Chilled Water, Glycol and chemical distribution systems (including NaOH and CIP chemicals)

Strong knowledge of GMP utilities systems and regulatory expectations

Proven ability to lead CQV execution independently

Strong understanding of IQ/OQ/PQ lifecycle

Excellent technical writing and documentation skills

Strong communication and cross-functional collaboration abilities

Detail-oriented with strong problem-solving skills

Onsite support in plant, mechanical, and cleanroom environments

Onsite support required in Holly Springs, NC

Preferred

Prior experience acting as a CQV Lead or system owner preferred

Experience supporting biotech, pharmaceutical, or cell & gene therapy facilities

Familiarity with automated utilities and building management systems (BMS)

Experience supporting regulatory inspections (FDA, EMA)

Experience on greenfield or large capital projects

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)