Associate Validation Specialist

Position Summary

Typical working hours are Monday – Friday 8 AM –5 PM. This position is 100% on-site in Winchester, Kentucky. Catalent’s Winchester location is the flagship U.S. manufacturing location for large‑scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry‑leading Glatt technology.

The Associate Validation Specialist position shall provide validation support and oversight of activities in facility, utility and equipment qualifications. The Associate Validation Specialist is responsible for drafting and approving documents, executing protocols on the manufacturing floor, drafting reports, attending customer meetings, supporting customer audits to provide validation support and to ensure they meet manufacturing timelines and maintain compliance.

• Meet with project managers to understand receipt/startup/manufacturing timelines and coordinate/perform validation activities in their area to meet these timelines.
• Direct facility and equipment validation activities, including facility and equipment risk assessments with review/approval of the facility and equipment change controls.
• Author specifications and protocols and execute validation documentation for facility and equipment in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Documentation includes specifications, protocols, reports and risk assessments.
• Execute protocols on the manufacturing floor, collect samples and track samples through to testing.
• Conduct periodic validation reviews for equipment and computerized systems.
• Support customer and agency audits with facility and equipment validation documentation and provide technical explanations.
• Assist in process development (NPIx), process validation and continued process verification efforts related to authoring and executing specifications and validation documentation for equipment/systems and processes in alignment with GMPs, FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity.
• Perform qualification activities in line with project schedules and timelines.
• Other duties in support of Catalent Pharma Solutions high performance.

• High school diploma required with 2+ years experience in pharmaceutical/biotechnology or medical devices industry, or associate’s degree when lacking industry experience.
• Experience authoring, reviewing and approving validation deliverables (risk assessments, test plans, protocols, reports, SOPs).
• Working knowledge of GxP, regulatory requirements for pharmaceutical industry (21 CFR part 11).
• Good documentation practices.
• Working knowledge of cGMP guidelines and regulations.
• Working knowledge of Track Wise and EDMS systems.
• Knowledge of validation SOPs and site quality policies.
• Excellent computer skills, scientific writing and general computer proficiency.
• Excellent organizational skills.
• Ability to interact and communicate with all departments/customers in person and via teleconferences.
• Proficient in English verbal and written communication.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work effectively under pressure to meet deadlines.
• Must be able to sit, stand, walk for extended periods and have sufficient vision for reading documents and using a computer monitor.

• Employee Resource Groups focusing on diversity and inclusion.
• Tuition reimbursement.
• Generous 401(k) match.
• 152 hours accrued PTO + 8 paid holidays.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

For reasonable accommodation during the application or hiring process due to a disability, please contact Disabili