Senior Validation Manager

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers validation and pharmaceutical manufacturing professionals the opportunity to support Phlow, a government-backed domestic API manufacturer focused on strengthening the nation's pharmaceutical supply chain through the reliable development and production of critical active pharmaceutical ingredients. We are seeking a Senior Validation Manager to support Phlow's pharmaceutical manufacturing operations in Petersburg, VAKey Responsibilities:Lead and implement site-wide CQV and validation strategies aligned with operational and regulatory requirementsManage external validation contractors and third-party partners currently supporting validation activitiesOversee validation efforts related to Manufacturing equipment, Clean utilities, HVAC systems and cleanrooms, Laboratory systems, Process automation and support systemsEstablish and maintain Validation Master Plans (VMPs) and lifecycle validation programsEnsure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocolsLead revalidation activities and support site readiness as manufacturing expandsDevelop, implement, and expand cleaning validation programs, including cleaning master plans, protocols, and supporting documentationSupport packaging configuration development for intermediate and finished goods, working closely with packaging partners and contract organizationsProvide oversight for stability programs and protocolsSupport technology transfer and new product introductions for upcoming manufacturing programsReview and approve validation protocols, reports, and related documentationEnsure compliance with FDA, EU GMP, ICH, and ISPE guidanceSupport deviations, CAPAs, change controls, audits, and regulatory inspectionsApply risk-based validation principles and lead validation-related risk assessmentsWork closely with operations, engineering, quality, and contractors in a highly visible, hands-on floor-based roleHelp build and scale an internal validation team as the site continues to growWork Schedule:Standard schedule is 40 hours/weekThis role is expected to be highly hands-on and floor-based, not strictly desk-basedFlexibility may be required to support off-hours work, urgent validation activities, or 24/7 manufacturing operationsStart date is needed as soon as possibleQualifications:Minimum Qualifications:Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related technical field8+ years of experience in pharmaceutical or biotech manufacturing5+ years of experience in a validation, CQV, or related leadership roleStrong pharmaceutical manufacturing background in a GMP-regulated environmentDemonstrated leadership experience managing validation teams, contractors, or third-party service providersStrong understanding of the full validation lifecycle and regulatory compliance requirementsAbility to manage broad validation scope across multiple functions, not just one specialty areaStrong communication, project management, and cross-functional collaboration skillsPreferred Qualifications:Master's degree in a related technical disciplineStrong experience with cleaning validation, including development of cleaning master plans and validation documentationExperience in API manufacturingExperience in a startup, growth-stage, or site build-out environmentExperience supporting packaging configurations and working with contract packaging organizationsExperience with stability programsExperience supporting regulatory inspections and auditsFamiliarity with Kneat, ValGenesis, TrackWise, or similar systemsKnowledge of DeltaV, Siemens, or other automation/control systemsPMP, ASQ CQE, ISPE membership, or similar industry certificationPLEASE APPLY ONLINEWhen you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren't contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

Created: 2026-05-10