Verista · 1 day ago
6119 - CQV Engineer / Senior Validation Engineer
Norton, MA
Full-time
Onsite
Senior Level
$70K/yr - $114K/yr
5+ years expVerista is a company that partners with leading brands in the life sciences sector to address critical healthcare challenges. They are looking for a Senior Validation Engineer to manage commissioning and qualification activities for manufacturing systems, ensuring compliance with regulatory standards and facilitating cross-functional collaboration.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
Responsibilities
Independently develop and execute Commissioning and Qualification (CQV) protocols including IQ, OQ, and PQ for manufacturing systems and equipment
Analyze test results, generate formal validation reports, and ensure all documentation complies with cGMP, GDocP, and regulatory standards
Proactively plan and manage CQV activities, provide input on validation timelines, and ensure alignment with overall project schedules and facility commissioning milestones, supporting both CapEx and OpEx initiatives
Serve as the validation representative on project teams, coordinating with Engineering, QA, Operations, and Automation teams to complete all validation lifecycle deliverables on schedule and in compliance with regulatory expectations
Review and interpret technical documentation (e.g., URS, FS, P&IDs, SOPs) to develop risk-based validation strategies, translate specifications into detailed test cases, and ensure that all functional and operational requirements are fully verified and documented
Provide clear and timely communication of validation status, deviations, risks, and remediation plans
Independently troubleshoot issues during commissioning and qualification, implement corrective actions, and maintain the system in a validated state
Qualification
Required
Must be able to meet on-site work requirements in Norton, MA
Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
5+ years of commissioning, qualification, and/or cleaning validation experience in a GMP biotech or pharmaceutical manufacturing environment
Proven ability to manage, prioritize, and execute tasks across multiple projects simultaneously
Strong proficiency in Good Documentation Practices within regulated environments
Willingness to occasionally work on-site outside of standard business hours to support validation activities as needed
Preferred
Automation & Control Systems Experience: Hands-on experience with automation commissioning and qualification, including operation of automated manufacturing equipment (Rockwell Plant PAx preferred)
Thermal Mapping & Requalification: Experience performing chamber temperature mapping, worst-case load justification, and periodic requalification reviews to confirm the validated state
Cleaning Validation Expertise: Experience with cleaning cycle development, rinse sampling, surface swabbing, and visual inspections to support cleaning validation or verification
Equipment & Software Exposure: Prior qualification/testing experience with process equipment (e.g., synthesizers, UF, HPLC, lyophilizers, CIP, WFI, clean utilities, cleanrooms) and systems using Unicorn software
Validation Systems & PLC Familiarity: Experience with electronic validation management systems (e.g., Veeva, Kneat, ValGenesis) and familiarity with PLC code/ladder logic to support testing and regression analysis
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.
501-1000 employees
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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase