Validation Engineer

Validation Engineer IIThe Validation Engineer II will support validation activities for GMP manufacturing facilities, utilities, equipment, laboratory systems, and processes within a regulated environment. The role is responsible for developing validation strategies, authoring lifecycle documentation, executing qualification protocols, and maintaining compliance with quality and regulatory requirements. This position works closely with cross-functional teams to ensure systems and processes remain in a validated state throughout their lifecycle.Key Responsibilities:Develop and execute validation strategies for GMP facilities, utilities, process equipment, laboratory systems, and analytical instrumentsAuthor and execute Validation Master Plans, qualification plans, and validation protocols using risk-based methodologiesDevelop and review User Requirements Specifications, functional requirements, risk assessments, and Requirements Traceability MatricesCreate and execute Installation Qualification, Operational Qualification, and Performance Qualification protocolsLead or support process validation, engineering studies, test method validation, and equipment qualification activitiesManage validation protocol execution to ensure timely completion and compliance with regulatory requirementsEvaluate validation results, investigate deviations, and prepare validation reports and corrective action documentationSupport commissioning, installation verification, startup activities, and transfer of systems into GMP operationsReview change control documentation and assess validation impact for process, equipment, and system changesTrack validation project progress and provide status updates to stakeholdersCollaborate with equipment vendors and internal teams during qualification and commissioning activitiesParticipate in internal and external audits and present validation status and recommendations during project reviewsProvide technical guidance and mentorship to less experienced team membersRequired Qualifications:Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality, or a related fieldMinimum 2 years of experience in validation, qualification, engineering, or quality within a regulated environmentExperience developing and executing validation lifecycle documentation including Validation Master Plans, User Requirements Specifications, risk assessments, and Requirements Traceability MatricesExperience executing Installation Qualification, Operational Qualification, and Performance Qualification activitiesKnowledge of GMP regulations, quality systems, and validation principlesExperience supporting change control, deviation investigations, and corrective action activitiesStrong technical writing, analytical, and problem-solving skillsAbility to work effectively within cross-functional teams and manage multiple prioritiesPreferred Qualifications:Master's Degree in a related fieldExperience validating GMP manufacturing equipment used in biotechnology, biologics, pharmaceutical, or oligonucleotide manufacturing environmentsHands-on experience with analytical instrumentation including HPLC systems, chromatography data systems, and spectrophotometersExperience with automated purification systems, tangential flow filtration, and chromatography platformsKnowledge of commissioning and qualification activities for manufacturing facilities, cleanrooms, laboratories, and utilitiesExperience collaborating with equipment vendors and reviewing vendor qualification documentationExperience supporting full validation lifecycle activities from commissioning through ongoing validated-state maintenanceBenefits:The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.Pay Range: $30/hr to $40/hr