CQV Engineer

CQV Engineer (Mid-Level)Job Type: Full-TimeLocation: Cambridge/Boston, MAWork Type: OnsiteCandidate Deck: CVQ EngineerAbout the OpportunityWe’re seeking a CQV Engineer to join our team at Pioneer GMP Consulting and support clients across pharmaceutical and biotech manufacturing environments in the Cambridge/Boston area.As part of our consulting team, you’ll operate as a trusted partner—embedded within client operations while remaining closely connected to and supported by Pioneer’s internal network of industry experts. You’ll play a key role in helping clients bring critical systems and facilities online safely, efficiently, and in compliance with GMP and regulatory expectations.In this role, you’ll support commissioning, qualification, and validation activities across a wide range of GMP systems, equipment, utilities, and manufacturing environments. Your work may span facility startups, capital projects, equipment qualification, operational readiness initiatives, and ongoing manufacturing support. Success in this role requires strong technical expertise, attention to detail, problem-solving ability, and the confidence to collaborate with stakeholders across Engineering, Manufacturing, Quality, and Validation teams.This is a long-term consulting opportunity—not a single project assignment. You’ll have the opportunity to contribute across multiple client engagements and gain exposure to diverse technologies, manufacturing processes, and facility types throughout the life sciences industry.What You'll DoSupport commissioning, qualification, and validation activities within GMP-regulated manufacturing environmentsExecute IQ/OQ/PQ protocols for facilities, utilities, process equipment, and manufacturing systemsParticipate in equipment startup, system walkdowns, turnover, and operational readiness activitiesIdentify and resolve discrepancies, documentation gaps, and commissioning issues during project executionCollaborate cross-functionally with Engineering, Manufacturing, Quality Assurance, Automation, and project teamsReview and support GMP documentation, including protocols, reports, deviations, change controls, and SOPsEnsure compliance with FDA regulations, cGMP requirements, ISPE guidance, and client quality standardsSupport facility expansions, capital projects, and manufacturing readiness initiativesCommunicate project updates, technical findings, and recommendations clearly to client stakeholdersContribute to continuous improvement initiatives that enhance compliance, reliability, and operational performanceQualifications3–7+ years of experience supporting CQV, validation, commissioning, or qualification activities within GMP-regulated pharmaceutical or biotech manufacturing environmentsStrong understanding of cGMP requirements, FDA regulations, validation lifecycle principles, and industry best practicesExperience executing or supporting IQ/OQ/PQ protocols for GMP facilities, utilities, equipment, or manufacturing systemsFamiliarity with commissioning, startup, turnover, and operational readiness activitiesFamiliarity with clean utilities, HVAC systems, automation systems, or process equipment qualificationExperience supporting regulated manufacturing operations, facility projects, or capital expansionsAbility to identify compliance, operational, and documentation gaps within GMP environmentsStrong technical writing skills, including protocol execution, report generation, deviations, and validation documentationAbility to work independently in a client-facing consulting environment while managing multiple prioritiesComfortable performing onsite field activities, system walkdowns, and cross-functional collaboration with Engineering, Manufacturing, and Quality teamsStrong communication, organization, and problem-solving skillsWillingness to work onsite in the Cambridge/Boston area and support client project needsWillingness to travel and work on-site in various locations.What Will Set You ApartStrong consultative mindset with the ability to build trust and collaborate effectively across client teamsExperience supporting large capital projects, facility startups, or manufacturing expansionsExperience within biologics, aseptic processing, cell & gene therapy, or other advanced therapy manufacturing environmentsExperience with Kneat, ValGenesis, Blue Mountain, or other electronic validation/documentation systemsAbility to translate technical and compliance requirements into clear, practical documentation and actionable solutionsThrives in structured, detail-oriented environments where quality, compliance, and execution are criticalProactively identifies gaps, drives continuous improvement, and supports operational excellence initiativesBuilds strong relationships and represents Pioneer with professionalism, credibility, and accountabilityPrior consulting experience within regulated pharmaceutical or biotech manufacturing environmentsExperience supporting FDA inspection readiness, audit support, or remediation initiativesCompensation & BenefitsCompetitive consulting rates commensurate with experience. Travel reimbursement and related expenses may apply depending on engagement requirements.Equal Opportunity EmployerPioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.