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6119 - CQV Engineer / Senior Validation Engineer

Norton, MA

Description

Verista’s 500 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

We are seeking a mid-to-senior level Validation Engineer to support both Opex and Capex projects in a pharmaceutical manufacturing facility. The role requires experience with automation commissioning and qualification of process equipment, including operation within a plant automation system (Rockwell PAx preferred, but not required)

Senior Validation Engineer Responsibilities:

  • Validation Execution & Documentation: 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
  • Project Planning & Scheduling: 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
  • Cross-Functional Collaboration: 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
  • Technical Interpretation & Testing Strategy: 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
  • Communication & Troubleshooting: 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

Preferred Experience:

  • 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

Requirements:

  • 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

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.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 - $113,521 USD

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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

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

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