Validation Specialist

Catalent’s Winchester location is the flagship U.S. manufacturing site for large‑scale oral dose forms, offering integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, the office brings industry‑leading Glatt technology to the region.

The Validation Specialist provides validation support and oversight across one or more of the following areas:
1) NPIx for new processes and equipment introduced at Catalent;
2) Process/Cleaning Validation for all Drug Products/APIs being commercialized;
3) Equipment Qualification for new equipment, change controls on existing equipment, and utilities/facility qualifications. The role serves as an extension of the Supervisor/Sr. Validation Specialist, handling documentation drafting, protocol execution, report creation, customer meetings, audit support, and compliance oversight.

• Draft protocols and reports for Computerized Systems Validation, Automated Production Equipment Validation, Facility Qualification, Analytical Equipment Validation, Process Validation, and Cleaning Validation. Develop protocol documents in line with current site and corporate Validation SOPs and guidelines, and obtain approval signatures from Catalent management and, when required, from customers.
• Execute approved protocols and coordinate activities with engineering, maintenance, production, and other departments as needed.
• Review and approve site annual product reviews.
• Assist in site NPIx gate reviews.
• Participate in customer audits, responding to audit observations and driving corrective actions.
• Investigate manufacturing or facility deviations on request from Quality Systems.
• Address process/facility change controls and CAPAs.
• Interact with customers, including scheduled teleconferences and responding to customer requests or complaints.
• Support additional duties as required to support Catalent Pharma Solutions high performance goals.

• Bachelor’s Degree preferred;
  Associate’s degree in life sciences (Pharmaceuticals, Chemistry, Biology, etc.) or related field required with at least 2 years’ experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience authoring, reviewing, and approving validation deliverables such as Risk Assessments, Test Plans, Protocols, Reports, Summary Reports, and SOPs.
• Scientific writing skills.
• Knowledge of cGMP guidelines and regulations.
• Proficiency in Microsoft Word, PowerPoint, and Excel, and working knowledge of Track Wise and EDMS systems.
• Knowledge of validation SOPs and site policies associated with the area of responsibility.
• Capability to sit for extended periods; vision requirements include reading written documents and frequent computer use.

• Employee Resource Groups focusing on diversity and inclusion.
• Tuition Reimbursement to support degree completion or new studies.
• Generous 401(k) match.
• 152 hours accrued PTO plus 8 paid holidays.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by emailing Disabili, including the job number, title, and location.