Validation Engineer

Work Schedule: Monday – Friday, 8:00 am to 5:00 pm – 100% on-site. Position Summary The Chelsea facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. This role is responsible for executing validation activities within a GMP manufacturing environment, including change control assessments and the review and approval of commissioning and validation documentation. Responsibilities Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and decision‑making on initiation of discrepancies. Author, review and approve validation and qualification documentation, including IQ, OQ, PQ, PPQ, validation plans, protocols, and summary reports in compliance with 21 CFR Part 210/211/11 and EU Annex 15. Author, review and approve validation deliverables for projects of varying scale; assess validation impact of changes to systems and processes. Generate, review and support deviations, CAPAs, and root‑cause investigations; develop, revise, review and approve SOPs, validation procedures, and test strategies while supporting ongoing site data integrity initiatives. Review and approve preventive maintenance and calibration plans, procedures, and associated documentation to ensure equipment remains in a validated state. Provide technical support to key site programs, including the cleaning program and CPV. Serve as a subject‑matter expert during internal and external audits and regulatory inspections; support vendor and service provider qualification activities. Other duties as assigned. Qualifications Bachelor’s degree required, preferably in an Engineering discipline. Minimum of 3 years of manufacturing or validation experience in a GMP environment. Strong understanding of FDA and EMA regulations and guidelines, including GAMP, ASTM E2500, ICH, USP, and 21 CFR Parts 210, 211, 11. Experience reviewing commissioning, validation, and qualification documentation such as validation master plans, FAT/SAT, traceability matrices, IQ/OQ/PQ, requirement specifications, and summary reports. Experience with process validation and cleaning validation protocols preferred. Experience with USP water systems, HVAC systems, critical utilities (nitrogen, clean air) and equipment qualification preferred. Prior audit experience preferred. Pay The anticipated salary range for this role in Massachusetts is $89,000.00 to $110,000.00 annually. The final salary offered may vary based on several factors. Equal‑Opportunity Employer Catalent is an Equal Opportunity Employer, including disability and veterans. Disability Accommodation If you require reasonable accommodation due to a disability, submit your request by email to View email address on click.appcast.io. Include the job number, title, and location. This option is reserved for individuals who require accommodation due to a disability. #J-18808-Ljbffr Catalent