6504 - Senior Lab CQV Engineer / Senior Validation Engineer

Job Overview

We are seeking a skilled Senior Lab CQV / Senior Validation Engineer with hands-on experience qualifying and validating a wide range of laboratory equipment and systems within a regulated pharmaceutical or life sciences environment.

Job Responsibilities

• Execute commissioning, qualification, and validation activities for laboratory instruments and systems, including IQ/OQ/PQ execution and protocol development
• Support qualification of both standalone and integrated laboratory equipment, including analytical and computerized laboratory systems
• Interface directly with laboratory personnel, engineering teams, QA, and instrument vendors to define testing scope, acceptance criteria, and qualification strategy
• Draft, review, and execute validation lifecycle documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, and change controls
• Perform impact assessments and risk assessments to determine system criticality, GxP impact, and qualification requirements
• Troubleshoot qualification issues, investigate deviations, and support root cause analysis activities during execution
• Maintain accurate, detailed, and compliant qualification documentation in accordance with cGMP and internal quality standards
• Support system integrations and assess data flow between laboratory instruments, software platforms, and enterprise systems
• Cookordination qualification activities with project schedules and cross-functional stakeholders to ensure timely project execution
• Ensure compliance with applicable regulatory requirements including FDA cGMP guidelines, data integrity expectations, and 21 CFR Part 11 requirements

Job Requirements

• Bachelor’s Degree in Engineering, Life Sciences, Computer Science, or related technical discipline preferred
• 4–6 years of experience in CQV, qualification, validation, or laboratory systems support within the pharmaceutical, biotech, or life sciences industry
• Direct hands-on experience qualifying complex laboratory instruments and systems in a regulated cGMP environment
• Strong knowledge of equipment qualification lifecycle activities including commissioning, IQ/OQ/PQ execution, deviation management, and change control
• Experience working with laboratory instrumentation such as HPLC, GC, TOC analyzers, balances, spectrophotometers, stability chambers, or similar analytical equipment preferred
• Understanding of computerized laboratory systems and system integrations is preferred, but primary focus is on equipment qualification and CQV execution
• Familiarity with risk-based validation approaches and data integrity requirements
• Knowledge of 21 CFR Part 11 and GxP compliance expectations
• Strong technical writing, communication, organizational, and problem-solving skills
• Ability to work independently with minimal oversight while collaborating effectively across functional teams

Company Culture

• 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

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
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement