Job Title : Validation EngineerJob Summary We are seeking an experienced Validation Engineer to support GMP validation activities in a pharmaceutical manufacturing environment. The ideal candidate will have strong hands‑on experience in equipment, process, cleaning, and/or computer system validation, and will work cross‑functionally with Manufacturing, Quality, Engineering, and Regulatory teams to ensure compliance with FDA and global regulatory requirements.Key ResponsibilitiesExecute and support validation lifecycle activities including URS, RA, IQ, OQ, PQ, and validation summary reports.Perform equipment validation for manufacturing, packaging, utilities, and laboratory systems.Support process validation and continued process verification (CPV).Execute cleaning validation studies and protocols in compliance with GMP requirements.Support computer system validation (CSV) activities in accordance with 21 CFR Part 11 and GAMP 5.Participate in change control, deviation investigations, CAPA, and risk assessments.Review and approve validation‑related SOPs, protocols, and reports.Collaborate with Manufacturing and Engineering teams during new equipment installation, upgrades, and technology transfers.Support regulatory inspections and audits (FDA, EMA, internal audits).Ensure validation activities comply with FDA, cGMP, ICH, and company quality standards.Required QualificationsBachelor's degree in Engineering, Life Sciences, or related field.5+ years of validation experience in the pharmaceutical industry.Strong hands‑on experience with GMP validation activities.Solid understanding of FDA regulations, including 21 CFR Parts 210, 211, and 11.Experience with risk‑based validation approaches (ICH Q9).Proficiency in validation documentation and technical writing.Ability to work cross‑functionally in a regulated manufacturing environment.Authorization to work in the USA.Preferred QualificationsExperience in biologics, sterile manufacturing, or aseptic processing.Hands‑on experience with utilities validation (HVAC, WFI, PW, compressed gases).Familiarity with ICH Q8, Q9, Q10 guidelines.Experience supporting FDA inspections.Knowledge of GAMP 5 and data integrity principles.Equipment / Systems Experience (Preferred)Manufacturing and packaging equipmentCleanroom systems and HVACUtilities (WFI, PW, clean steam, compressed air)Laboratory instrumentsComputerized systems (MES, LIMS, SCADA, EMS)Seniority levelMid‑Senior levelEmployment typeContractJob functionScience and EngineeringIndustriesPharmaceutical Manufacturing and Biotechnology ResearchLocation: Clayton, NCSalary: $114,000.00 - $128,000.00#J-18808-Ljbffr