Validation Engineer

Catalent Pharma Solutions•Chelsea, MA

7d•$89,000 - $110,000•Onsite

About The Position

The Validation Engineer 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 (protocols, reports, work orders, calibration, and preventive maintenance records). This role supports commissioning and qualification efforts across areas such as DQ, FAT, SAT, IQ, OQ, PQ, requalification, cleaning, sterilization/sanitization, computer systems, and process validation (PV). The position ensures all validation activities are scientifically sound, compliant, and aligned with regulatory requirements. The Chelsea facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America.

Requirements

Bachelor’s degree is required; Preferably in an Engineering discipline
Minimum of 3 years of Manufacturing or Validation experience in a GMP manufacturing environment is required
Strong understanding of FDA and EMA regulations and guidelines, including GAMP, ASTM E2500, ICH, USP, and 21 CFR Parts 210, 211, and 11 is required
Experience reviewing commissioning, validation, and qualification documentation such as Validation Master Plans, FAT/SAT, traceability matrices, IQ/OQ/PQ, requirement specifications, and summary reports is required

Nice To Haves

Experience with process validation and cleaning validation protocols is preferred
Experience working with USP water systems, HVAC systems, and critical utilities (e.g., nitrogen, clean air), as well as equipment qualification is preferred
Prior audit experience preferred

Responsibilities

Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions 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, including protocols, reports, and supporting documentation, and assess the validation impact of changes to systems and processes
Generate, review, and support deviations, CAPAs, and root cause investigations, working closely with Quality Assurance to ensure timely and compliant resolution, including validation-related deviations
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 (cleaning validation, cleaning chemistry, and master plan) and Continued/Continuous Process Verification (CPV)
Serve as a Subject Matter Expert (SME) during internal and external audits and regulatory inspections
Support vendor and service provider qualification activities, including participation in audits as required
Other duties as assigned