POSITION OVERVIEW:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your TALENTS, IDEAS and PASSION are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Catalent's Winchester, Kentucky location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.

POSITION SUMMARY:

The Associate Validation Specialist position shall also provide support for process validation and cleaning validation as well as its related support areas, NPIx development, process validation, continued process verification and cleaning activities. The Associate Validation Specialist position shall also provide validation support for Facilities, Utilities and Equipment/Automated Equipment/Analytical Equipment that have been newly installed, upgraded, replaced and/or modified in a cGMP Manufacturing Facility as well as its related support areas, which may include Facilities/Engineering, Quality Assurance, Supply Chain, and Quality Control.

• The Associate Validation Specialist position shall provide validation support for process validation, which may include NPIx development, validation of processes or continued process verification.
• The Associate Validation Specialist position shall provide validation support for cleaning validation, which may include cleaning process development, validation of cleaning processes or continued process verification.
• The Associate Validation Specialist position shall provide validation support for Facilities, Utilities and Equipment/Automated Equipment/ Analytical Equipment that have been newly installed, upgraded, replaced and/or modified in a cGMP Manufacturing Facility as well as its related support areas, which may include Facilities/Engineering, Quality Assurance, Supply Chain, and Quality Control.
• The Associate Validation Specialist is responsible for generating, reviewing and approving system assessments, test scripts, change controls, process improvements and compliance governance at all applicable points of the equipment/system, process/cleaning life cycle. They will collaborate with business partners to maintain and improve processes to ensure robust, efficient, and compliant processes.
• In concert with Catalent's Patient First philosophy, this role ensures that regulatory compliance is maintained for the implementation of new equipment/systems and remediation to existing systems which are used for the manufacture of drug products. This position shall provide oversight to facilities/utilities and equipment systems periodic reviews and audit trail/user access reviews and maintain equipment/systems in compliance. This position shall provide support for facilities/utilities and equipment which are essential in the manufacture of quality products. These products are delivered for use in our customer's clinical studies, which promote future marketed medicines.

WORK HOURS: MONDAY - FRIDAY BUSINESS DAY

THE ROLE:

• Assist in process development (NPIx), process validation and continued process verification efforts related to authoring and executing specifications and validation documentation for 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.

THE CANDIDATE:

• Bachelor's degree in life sciences (e.g., Chemistry, Biology, etc.) or related field (Engineering, Industrial Hygiene, etc.).
• 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 .

KNOWLEDGE/SKILLS REQUIREMENTS:

• Proficiency in Microsoft Word, PowerPoint and Excel (graph and perform simple statistics using an Excel spreadsheet)
• Scientific writing skills
• Ability to complete metric conversions and perform general mathematical calculations
• Good communication skills, able to collaborate effectively with other people / groups / customers

PHYSICAL REQUIREMENTS:

Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

CATALENT'S STANDARD LEADERSHIP COMPETENCIES

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

WHY YOU SHOULD JOIN CATALENT:

• Medical, Dental, Vision and 401K are all offered from day one of employment
• 19 days of paid time off annually
• Potential for career growth within an expanding team
• Defined career path and annual performance review and feedback process

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.

Catalent is committed to the health and safety of its employees, visitors and the customersand patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

IMPORTANT SECURITY NOTICE TO U.S. JOB SEEKERS:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.