Validation Specialist

Catalent•Winchester, KY

3d•Onsite

About The Position

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 oversite 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. 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.

Requirements

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
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

Nice To Haves

Bachelor's Degree preferred.

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.
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