Senior Pharmaceutical CQV Engineer

Job Description #11729 / #11728Introduction:Visium Resources has been asked to identify qualified candidates for this Pharmaceutical Senior CQV Engineer position. This position is a direct hire, and worksite is on-site in Boulder, CO. Employer will consider candidates outside commuting distance who will be provided monthly expenses for the right candidate to commute to this location.Summary:We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations.This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.Key Responsibilities:Lead and execute CQV activities for pharmaceutical and biotech capital projects.Develop and execute:Commissioning plansIQ/OQ/PQ protocolsValidation test scriptsTraceability matricesSummary reportsSupport startup and qualification of:Process equipmentClean utilitiesHVAC systemsManufacturing suitesAutomation and control systemsCoordinate field execution activities with engineering, construction, vendors, and operations teams.Perform system walkdowns and turnover package reviews.Support deviation investigations, CAPAs, and change control activities.Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.Participate in FAT/SAT execution and acceptance activities.Support project schedule development and milestone tracking.Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.Mentor junior CQV engineers and validation specialists as needed.Required Qualifications:Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.5-10+ years of CQV, validation, or pharmaceutical engineering experience within GMP-regulated environments.Strong knowledge of:cGMP regulationsFDA validation requirementsISPE Baseline GuidesGAMP 5 principlesExperience executing commissioning and qualification for:Process equipmentUtilitiesHVAC systemsCleanroomsAutomation systemsExperience authoring and reviewing validation lifecycle documentation.Strong technical writing and documentation skills.Ability to work independently within fast-paced project environments.Preferred Qualifications:Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.Previous consulting experience within life sciences industries preferred.Familiarity with:DeltaVMES systemsSCADA platformsKneat or electronic validation systemsPMP certification or equivalent project leadership experience is a plus.Strong client-facing communication and leadership skills.Additional Skills & Competencies:Excellent organizational and multitasking abilitiesStrong problem-solving and analytical skillsAbility to manage multiple priorities and deadlinesComfortable working in both office and field environmentsAbility to travel to client sites as required_____________________________________________________________________________________Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.Company Description Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never "just a number". You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need. Company Description Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never "just a number". You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.