6444 - Lead CQV Engineer / Lead Validation Engineer

Veristainc; Harvard (MA); On-site; USD 87,800 - 147,123; Full time

Benefits offered by this job

Life Insurance

Disability Insurance

Medical Insurance

Dental Insurance

Vision Insurance

401k matching

Paid Time Off

Tuition Reimbursement

Parental Leave

Team events

Job summary

Verista seeks a Lead Validation Engineer to head C&Q scope for drug product filling, isolator, and related aseptic systems at Devens, MA. This on-site role requires expertise in vial filling, isolator qualification, and handling QA interactions.

You will manage SAT/IOQ/IOQ activities, coordinate vendor packages, and drive final qualification reports with cross‑functional teams in a fast-paced, healthcare‑focused environment.

Qualifications

• Bachelor’s Degree or equivalent required.
• 10+ years aseptic filling, sterile manufacturing, isolator, or barrier‑system CQV experience.
• Direct vial filler/capper, isolator, inspection/labeling, VHP/decontamination, glove integrity, leak testing, sterile boundary, environmental monitoring, or Annex 1‑aligned experience.
• Strong field execution profile: coordinate vendor SAT, manage punch items, document discrepancies, support deviations, and drive final qualification reports.
• Comfort working with quality reviewers on sterile manufacturing risks, critical parameters, acceptance criteria, and evidence expectations.
• Strong technical writing and problem‑solving abilities.
• ValGenesis experience a plus.

Responsibilities

• Own filler/isolator‑related QP/DQ/QRA/data integrity/ERES/configuration/traceability inputs as applicable, plus SAT leveraging, commissioning, IOQ, QSR, blue tag, and PQ readiness where required
• Coordinate vendor documentation and execution windows for filler/capper, isolator, labeler, inspection equipment, and associated sterile manufacturing systems
• Support interface with cleanroom/room qualification, environmental monitoring instruments, utilities, automation/IT, operations, MS&T, and quality
• Manage sterile equipment risks, test exceptions, deviations, punch items, and closeout evidence through final report approval
• Lead filler/isolator C&Q scope
• Coordinate vendor package review
• Support VHP/sterile boundary questions if in scope
• Author/review IOQ/QSR/TM

Skills

Vendor coordination

SAT coordination

Punch item management

Discrepancy documentation

Deviations support

Final qualification reports

Technical writing

Problem solving

Quality reviewer collaboration

Education

Bachelor’s Degree or equivalent

Tools

ValGenesis

Job description

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

Job Overview

We are seeking a Lead Validation Engineer to lead C&Q scope for drug product filling, isolator, and related aseptic manufacturing equipment. This is a specialist role for someone who has qualified vial filling/capping and isolator systems and can manage sterile boundary risk, vendor package questions, SAT/IOQ execution issues, and quality‑facing closeout.

Lead Validation Engineer Responsibilities

• Own filler/isolator‑related QP/DQ/QRA/data integrity/ERES/configuration/traceability inputs as applicable, plus SAT leveraging, commissioning, IOQ, QSR, blue tag, and PQ readiness where required
• Coordinate vendor documentation and execution windows for filler/capper, isolator, labeler, inspection equipment, and associated sterile manufacturing systems
• Support interface with cleanroom/room qualification, environmental monitoring instruments, utilities, automation/IT, operations, MS&T, and quality
• Manage sterile equipment risks, test exceptions, deviations, punch items, and closeout evidence through final report approval
• Lead filler/isolator C&Q scope
• Coordinate vendor package review
• Support VHP/sterile boundary questions if in scope
• Author/review IOQ/QSR/TM

Job Requirements

• Bachelor’s Degree or equivalent required
• 10+ years aseptic filling, sterile manufacturing, isolator, or barrier‑system CQV experience
• Direct vial filler/capper, isolator, inspection/labeling, VHP/decontamination, glove integrity, leak testing, sterile boundary, environmental monitoring, or Annex 1‑aligned experience
• Strong field execution profile: can coordinate vendor SAT, manage punch items, document discrepancies, support deviations, and drive final qualification reports
• Comfort working with quality reviewers on sterile manufacturing risks, critical parameters, acceptance criteria, and evidence expectations
• Strong technical writing and problem‑solving abilities
• ValGenesis experience a plus

This role requires the ability to be on‑site, full‑time in Devens, MA.

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

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

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

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: $87,780 – $147,123 USD