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Verista · 13 hours ago

6078 - Senior CQV Engineer / Senior Validation Engineer

Holly Springs, NC

Full-time

Onsite

Senior Level

$70K/yr - $118K/yr

6+ years exp

Verista is a company that partners with leading brands in the life science industry to address significant healthcare challenges. The Senior CQV Engineer will lead and execute commissioning, qualification, and validation activities for CIP systems in Drug Substance Manufacturing while ensuring compliance with regulatory and internal quality standards.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations

Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities

Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports

Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions

Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria

Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing

Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria

Support residue, bioburden, and TOC sampling strategies as part of cleaning validation

Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations

Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance

Provide validation support during tech transfers, process changes, and new equipment installations

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

Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation

Support internal and external audits and regulatory inspections

Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams

Provide guidance and mentoring to junior CQV engineers and validation resources as needed

Qualification

CQV experienceCIP system qualificationCleaning validationGMP documentationDrug Substance ManufacturingTechnical writingProblem-solvingBiopharmaceutical knowledgeAutomated CIP systemsCross-functional collaborationMentoringCommunication skillsAttention to detail

Required

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

6+ years of hands-on experience in CQV / Validation within a GMP manufacturing environment

Strong experience with CIP systems, including:

CIP system qualification (IQ/OQ/PQ)

Cleaning Validation in CIP

CIP cycle development and optimization

Demonstrated experience supporting Drug Substance Manufacturing operations

Deep understanding of CIP system design, qualification, and validation

Strong knowledge of cleaning validation principles and regulatory expectations

Experience with GMP documentation and validation lifecycle

Ability to work independently and lead validation activities

Strong technical writing and communication skills

Detail-oriented with strong problem-solving abilities

Experience with automated CIP systems and process control

Familiarity with biopharmaceutical or biotech manufacturing environments

Experience supporting regulatory inspections (FDA, EMA)

Prior experience mentoring or leading validation efforts

Onsite presence in manufacturing and cleanroom environments

Onsite presence required in Holly Springs, NC

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)

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Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)