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Associate Validation Specialist - Winchester Kentucky
Company: Disability Solutions
Location: Winchester, Kentucky
Posted On: 01/19/2025
Associate Validation SpecialistPosition SummaryCatalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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 Associate Validation Specialist position shall provide support for cleaning validation as well as its related support areas; NPIx development, validation of analytical test methods, cleaning validation, and continued process verification. The Associate Validation Specialist position shall also provide validation support for change control to validated systems using TrackWise, and validation support during customer and agency audits / interaction with customers. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role - Direct cleaning validation activities; including drafting NPIx risk assessments with review / approval of the NPIx change controls.
- Direct cleaning validation activities; including authoring and executing specifications and validation documentation for equipment cleaning processes in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity.-- Validation documentation includes CV protocols/CV reports and Risk Assessments.
- Direct cleaning validation activities; including execution of protocols / training on the manufacturing floor, collection of samples and tracking samples through to testing.
- Direct cleaning validation activities; including overseeing the Cleaning Validation Master Plan and associated continued process verification monitoring activities.
- Support of customer and agency audits with cleaning validation documentation and speaking to the data provided.
- 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 Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity.-- Validation documentation includes NPIx development protocols/reports, Process Validation protocols/reports, Continued Process Verification (CPV) plans/reports, Risk Assessments, and Annual Product Reviews (APRs).
- Performs qualification activities in line with the project schedules and timelines.
- Collaborates validation/qualification activities with key stakeholders.
- Supports customer and agency audits.
- Other duties as assigned. The Candidate
- HS Diploma Required.
- Bachelor's degree in Life Sciences (e.g., Chemistry, Microbiology, etc.) OR a minimum of (3) years of pharmaceutical experience in the area of validation, operations, quality control and/or quality systems required.
- Knowledge of cGMP guidelines and regulations
- Proficiency in Microsoft Word, PowerPoint and Excel
- Working knowledge of TrackWise software
- Knowledge of SOPs pertaining to Catalent Pharma Solutions validation of facility, utility, equipment, and computerized systems
- Ability to read and understand system schematics, piping, both mechanical and electrical
- Ability to complete metric conversions and perform general mathematical calculations
- Ability to interact and communicate with all departments / customers in person and on teleconferences
- Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.--
- Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.Why You Should Join Catalent
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