6504 - Senior Lab CQV Engineer / Senior 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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 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. The ideal candidate will have direct experience executing commissioning and qualification activities independently, collaborating with laboratory stakeholders and instrument vendors, and supporting lifecycle validation activities for both simple and complex laboratory instrumentation. Job Responsibilities: Execute commissioning, qualification, and validation activities for laboratory instruments and systems, including IQ/OQ/PQ execution and protocol developmentSupport qualification of both standalone and integrated laboratory equipment, including analytical and computerized laboratory systemsInterface directly with laboratory personnel, engineering teams, QA, and instrument vendors to define testing scope, acceptance criteria, and qualification strategyDraft, review, and execute validation lifecycle documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, and change controlsPerform impact assessments and risk assessments to determine system criticality, GxP impact, and qualification requirementsTroubleshoot qualification issues, investigate deviations, and support root cause analysis activities during executionMaintain accurate, detailed, and compliant qualification documentation in accordance with cGMP and internal quality standardsSupport system integrations and assess data flow between laboratory instruments, software platforms, and enterprise systemsCoordinate qualification activities with project schedules and cross-functional stakeholders to ensure timely project executionEnsure 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 preferred4–6 years of experience in CQV, qualification, validation, or laboratory systems support within the pharmaceutical, biotech, or life sciences industryDirect hands-on experience qualifying complex laboratory instruments and systems in a regulated cGMP environmentStrong knowledge of equipment qualification lifecycle activities including commissioning, IQ/OQ/PQ execution, deviation management, and change controlExperience working with laboratory instrumentation such as HPLC, GC, TOC analyzers, balances, spectrophotometers, stability chambers, or similar analytical equipment preferredUnderstanding of computerized laboratory systems and system integrations is preferred, but primary focus is on equipment qualification and CQV executionFamiliarity with risk-based validation approaches and data integrity requirementsKnowledge of 21 CFR Part 11 and GxP compliance expectationsStrong technical writing, communication, organizational, and problem-solving skillsAbility to work independently with minimal oversight while collaborating effectively across functional teams This is a 100% on-site role in Muskegon, MI. 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: $69,300 USD - $95,358 USD Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid 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