6445 - Lead CQV SME / Lead Validation Engineer

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 provide senior technical governance across the C Q lifecycle for a mixed portfolio of facility, utility, process equipment, analytical instrument, automation, and room qualification scope. This role is the technical backstop for strategy, deliverable quality, risk-based qualification rationale, protocol comments, deviation handling, and execution readiness.

Lead Validation Engineer Responsibilities:

Provide senior technical governance for commissioning, qualification, and validation activities across facilities, utilities, process equipment, analytical instruments, automation systems, and cleanroom qualifications. Ensure qualification strategies align with regulatory expectations, industry best practices, project objectives, and quality requirements

Mentor and provide technical oversight to system leads and CQV engineers, offering guidance on qualification execution, risk-based decision making, protocol development, technical problem solving, and regulatory compliance while promoting consistency across multiple workstreams

Review and approve system qualification strategies including Commissioning Plans, Qualification Plans, Validation Master Plans (VMPs), and lifecycle deliverables to ensure appropriate application of risk-based commissioning and qualification methodologies in accordance with ASTM E2500, ISPE Baseline Guides, and GAMP 5 principles

Provide technical leadership in resolving complex protocol execution, deviation, and investigation issues, evaluating technical impact, determining appropriate corrective actions, and ensuring timely closure of deviations while maintaining project schedules and compliance with cGMP requirements

Support vendor leveraging and risk-based qualification approaches by evaluating vendor documentation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning packages for qualification suitability. Develop and review Quality Risk Assessments (QRA), Design Qualifications (DQ), Installation/Operational Qualification (IOQ) strategies, Qualification Summary Reports (QSR), and Traceability Matrices (TM) to optimize testing while ensuring complete regulatory compliance

Review and guide QP, QRA, data integrity risk assessment, ERES assessment, configuration specification, traceability matrix, commissioning protocol/report, IOQ/PQ, blue tag, and QSR strategy

Own technical escalation for protocol exceptions, discrepancies, punch items, deviations, and test evidence gaps

Support family/grouping rationale where systems can be qualified efficiently while maintaining traceability and defensibility

Partner with PM and document manager to keep 5-business-day review and approval cycles realistic and clean

Job Requirements:

Bachelor’s Degree or equivalent required

15+ years in GMP CQV, ideally across biologics, viral vector, cell therapy, gene therapy, aseptic manufacturing, or complex sterile facilities

Strong risk-based qualification judgment: can decide when to leverage vendor FAT/SAT packages, when to write project-specific testing, and how to defend the rationale to quality stakeholders

Experience reviewing direct impact systems, computerized/automation interfaces, analytical instruments, utilities, cleanrooms, and process equipment without becoming a bottleneck

Able to mentor system leads, normalize document quality, resolve comments, and prevent drift across parallel system deliverables

Deep knowledge of GMP validation lifecycle.

Extensive experience with ASTM E2500, ISPE, GAMP 5, FDA, and EU Annex 15.

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.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a …