Validation Specialist

About the role

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 Specialists shall provide validation support and oversight of activities in one or more of the following areas: 1) NPIx for new processes and equipment brought into the Catalent facility, 2) Process/Cleaning Validation activities for all Drug Products/APIs being commercialized and/or 3) Equipment Qualification for all new Equipment/Systems, change controls to existing qualified Equipment/Systems and utilities/facility qualifications.

Responsibilities

• 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.
• Develop the appropriate and required protocol documents in accordance with the current site and corporate Validation SOP’s and guidelines.
• Obtain 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.
• Involvement with customer audits and responding to audit observations and corrective actions.
• Affording process/facility Change Controls issued.
• Affording process/facility CAPAs issued.
• Interacting with customers, including participating in scheduled teleconferences and responding to customer requests/complaints.

Requirements

• 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 TrackWise and EDMS systems.
• Working knowledge of cGMP guidelines and regulations, Knowledge of validation SOPs and site policies associated to their area.

Qualifications

• Specific vision requirements include reading of written documents and frequent use of computer monitor.

Skills

• Personal initiative.
• Dynamic pace.
• Meaningful work.

Benefits

• 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.

Pay

• N/A

Schedule

• N/A