Validation Engineer

About the role

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.

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

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
• 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

Qualifications

• Pay: The anticipated salary range for this role in Massachusetts is $89,000.00 to $110,000.00 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
• Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Company

• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
• Join us in making a difference.

Contact

• If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com.
• This option is reserved for individuals who require accommodation due to a disability.
• Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.