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Computer Systems Validation Lead

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Computer Systems Validation Lead provides direct computer systems validation support to pharmaceutical development, analytical/microbiology laboratories, and manufacturing operations. The Computer Systems Validation Lead performs technical and quality functions to ensure accurate execution and documentation of all activities and projects as assigned.

Regular working hours: Monday - Friday; 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch.

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

• Performs Computer Systems Validation by authoring and reviewing process validation protocols and summary reports, conducting validation testing, analyzing data to determine acceptability, identifying deviations, approving technical documents, and managing periodic reviews and revalidations for computer systems.

• Conducts Equipment/Facilities/Utilities Qualification by authoring and reviewing qualification protocols and summary reports for equipment, assisting with protocol execution, approving technical engineering and facility documents, and managing periodic reviews and revalidations, as well as mapping and remapping for the site.

• Manages the Site Master Validation Program by overseeing and administering the program, updating and maintaining the site validation master plan in accordance with company and industry regulations, assisting in the development of validation policy, and preparing and maintaining a validation life cycle approach for the site.

• Train and mentor entry level personnel and provide guidance to peers.

• Recommend validation strategies to support computer systems and equipment validation.

• Assist in the implementation for improved site validation activities and the quality systems related to these activities.

• Participate in and provide direct support for client and regulatory audits.

• Perform other duties as assigned.

The Candidate

• Bachelor’s degree in a Technical or Life Sciences discipline with at least 8 years of experience in the pharmaceutical industry and at least 6 years in validation (or)

• Associate degree in a Technical or Life Sciences discipline with at least 10 years of experience in the pharmaceutical industry and at least 8 years in validation (or)

• In lieu of Technical/Life Sciences degree, a bachelor’s degree with at least 6 years of experience in the pharmaceutical industry and at least 2 years in the areas of Equipment/Facilities and Computer Validation as a substitute is required.

• 3+ years of experience in one or more of the following areas: Computer systems and CFR 210 Part 11 software validation, equipment (lab/mfg./pkg.) validation, laboratory method validation, or process/cleaning validation

• Direct experience preparing and implementing validation protocols and authoring validation summary reports

• Some exposure to hazardous chemicals and other active chemical ingredients

• Position requires the capacity to handle and manipulate objects using hands and arms.

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Why You Should Join Catalent

• Medical, dental, and vision insurance.

• 401(k) retirement savings plan with company match.

• Fast-paced, dynamic environment.

• 152 hours of PTO + 8 paid holidays.

• Opportunity to work on Continuous Improvement Processes.

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 (https://careers.catalent.com/us/en) 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.

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.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .