Associate Validation Specialist

Associate Validation Specialist

Position Summary

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.

Working Hours: Monday-Friday 8 AM-5 PM. This role will be 100% on-site in Winchester Kentucky.

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 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.

• Other duties as assigned.

The Candidate

• Associates Degree or Bachelors Degree in life sciences (e.g. Chemistry Biology etc.) or related field.

• Experience in the Pharmaceutical Biotechnology or Medical Devices industry (e.g. in the area of quality control and/or quality assurance) a plus but not required.

• Working knowledge of GxP regulatory requirements for pharmaceutical industry (i.e. 21 CFR part 11) and good documentation practices a plus but not required.

• Proficiency in Microsoft Word PowerPoint and Excel (basic graphing with statistical analysis of data)

• Technical Writing Experience Preferred.

• File/Folder storage with non-repetitive light weight lifting reaching and forward bending as necessary. 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. Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

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 7000 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 . 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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