Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.Description:Join our validation engineering team as a Validation Engineer III (Computer Systems Validation – CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.In this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.A Day in the Role:Lead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSVEvaluate and support change management for existing manufacturing systems and automation platformsAuthor, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plansPerform and lead risk assessments, gap analyses, and validation assessmentsCollaborate with automation engineers on systems such as PLC, SCADA, DCS, DeltaV, and Allen-Bradley platformsIndependently manage validation projects and coordinate cross-functional teamsProvide technical expertise during regulatory inspections and client auditsMentor junior team members and support knowledge sharing across the teamContribute to continuous improvement and operational excellence initiativesRequirements:Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical fieldEquivalency:Equivalent combinations of education, training, and relevant experience may be considered in place of a degreeMinimum of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industryStrong knowledge of cGMP regulations (FDA, EMA, ISO)Experience with Computer Systems Validation (CSV), CQV, or automation validationExperience writing and executing IQ/OQ/PQ validation protocolsExperience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)Proven ability to lead validation projects and work cross-functionallyStrong technical writing and documentation skillsExperience with risk assessment methodologies and statistical analysisAdvanced problem-solving and root cause analysis skillsExcellent verbal and written communication skillsProficiency with MS Office and validation-related systemsPreferred:Experience supporting or contributing to capital (CapEx) projectsExperience with regulatory inspections and client auditsKnowledge of lean manufacturing and continuous improvement methodologiesAdditional Information:Ability to work in cleanroom environments as requiredFlexibility to support extended hours or off-shift work during project activities or shutdownsMay require up to 25% travel