Validation Specialist

Validation Specialist

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 US 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 Validation Specialist shall provide validation support and oversight of activities in one or more of the following areas; NPIx for new processes and equipment brought into the Catalent facility, Process/Cleaning Validation activities for all Drug Products/APIs being commercialized, and Equipment Qualification for all new Equipment/Systems, change controls to existing qualified Equipment/Systems and utilities/facility qualifications. The Validation Specialist is an extension of the Supervisor/Sr.

Validation Specialist on all validation activities, including drafting and approving documents, execution of 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 to maintain compliance.

The Role

• Draft protocols and reports for Computerized Systems Validation, and/or Automated Production Equipment Validation, and/or Facility Qualification, and/or Analytical Equipment Validation, and/or Process Validation and/or Cleaning Validation. Responsibilities include developing the appropriate and required protocol documents in accordance with the current site and corporate Validation SOP's and guidelines. Obtaining approval signatures from the Catalent management and as required from customers.
• Execute approved protocols and coordinate the activities with other departments (e.g. engineering, maintenance, production, etc…) as required.
• Review and approve site Annual Product reviews.
• Assists in site NPIx gate reviews.
• Involvement with customer audits and responding to audit observations and corrective actions.
• Assist in investigations of manufacturing/facility deviations as asked of by Quality Systems.
• Addressing process/facility Change Controls issued.
• Addressing process/facility CAPAs issued.
• Interacts with customers, including participating in scheduled teleconferences and responding to customer requests/complaints.
• Other duties as required in support of Catalent Pharma Solutions high performance

The Candidate

• Bachelor's Degree preferred.
• Associates degree in life sciences (e.g., Pharmaceuticals, Chemistry, Biology, etc.) or related field required with 2 years experience in the Pharmaceutical/Biotechnology or Medical Devices industry; OR Experience in authoring, reviewing and approving of validation deliverables including Risk Assessments, Test Plans, Protocols, Reports, Summary Reports and Standard Operating Procedures (SOPs).
• Scientific writing skills
• Knowledge of cGMP guidelines and regulations, proficiency in Microsoft Word, PowerPoint and Excel, working knowledge of Track Wise and EDMS systems.
• Working knowledge of cGMP guidelines and regulations,
• Knowledge of validation SOPs and site policies associated to their area.
• Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Generous 401K match
• 152 hours accrued PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. 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.

Personal initiative. Dynamic pace. Meaningful work.

Visit Catalent Careers to explore career opportunities.

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