Associate Validation Specialist

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 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 validation support and oversite of activities in facility, utility, and equipment qualifications. The Associate Validation Specialist is responsible for 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

• 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.

• Direct facility and equipment validation activities; including authoring specifications and protocols and executing validation documentation for facility and equipment in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes specifications, protocols, reports and risk assessments.

• Direct validation activities; including execution of protocols on the manufacturing floor, collection of samples and tracking samples through to testing.

• Direct validation activities; including conducting periodic validation reviews for equipment and computerized systems.

• Support of customer and agency audits with facility and equipment 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.

• Supports customer and agency audits.

• Other duties as required in support of Catalent Pharma Solutions high performance

The Candidate

• HS Diploma required with 2+ years experience in Pharmaceutical/ Biotechnology or Medical Devices industry. Associate’s Degree required when individual has no experience in the Pharmaceutical/ Biotechnology or Medical Devices industry.

• Experience in authoring, reviewing and approving of validation deliverables including Risk Assessments, Test Plans, Protocols, Reports, Summary Reports and Standard Operating Procedures (SOPs).

• Must have working knowledge of GxP, regulatory requirements for pharmaceutical industry (i.e. 21 CFR part 11)

• Must have good documentation practices.

• Working knowledge of cGMP guidelines and regulations

• Working knowledge of TrackWise and EDMS systems.

• Knowledge of validation SOPs and site quality policies

• Requires excellent computer skills and general knowledge of computerized systems, and scientific writing skills

• Excellent organizational skills

• Ability to interact and communicate with all departments / customers in person and on teleconferences.

• Proficient in English verbal and written communication skills

• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint)

• Ability to work effectively under pressure to meet deadlines

• Individual may be required to sit, stand, walk 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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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