IT CSV ERP Manager

IT CSV ERP Manager

Position Summary:

The IT CSV ERP Manager has a primary focus to partner with the Business and System Owners, Quality, and the Global IT Computer Systems Validation (CSV) Director to define and execute Catalent's ERP and Manufacturing System's Validation with strong risk-based approach, support internal and external audits, and identify opportunities to improve Catalent's CSV methodology.

This leadership position reports to the Director of Global IT Compliance and Operations and will work closely with the other members of the organization to meet the goals of the program. The IT CSV ERP Manager will provide leadership for a CSV team of 6 to 8 CSV consultants and external partners. Qualifications include a strong background in ERP Systems, Computer System Validation, and Sarbanes Oxley (SOX) financial system regulations.

The IT CSV ERP Manager will be responsible for developing the strategy for the validation of Catalent's centrally managed ERP and Manufacturing Systems (such as JD Edwards, SAP, Werum, Serialization and etcetera), leading its execution, escalating risks and opportunities in a timely manner, and providing periodic status reports to the Global IT Compliance and Operations Director, Project Stakeholders, and the VP of Global CSV and IT Compliance.

Location: Remote

The Role:

• Partner with the Business and System Owners, Quality, and the Global IT Computer Systems Validation (CSV) Director to define and execute Catalent's ERP and Manufacturing System's Validation with strong risk-based approach
• Support internal and external audits, and identify opportunities to improve Catalent's CSV methodology
• Develop the strategy for the validation of Catalent's centrally managed ERP and Manufacturing Systems (such as JD Edwards, SAP, Werum, Serialization and etcetera)
• Lead strategy execution, escalating risks and opportunities in a timely manner
• Provide periodic status reports to the Global IT Compliance and Operations Director, Project Stakeholders, and the VP of Global CSV and IT Complianc
• Other duties as assigned

The Candidate:

• Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
• 7+ years experience working in pharmaceutical manufacturing environment
• 5+ years experience with Computer System Validation
• Experience in validation of Enterprise Resource Planning systems (ie. JDE, SAP, Etc.)
• Experience in dealing with both GxP and SOX/Financial requirements
• Ability to travel up to 25% domestic and international

Why you should join Catalent:

• Competitive medical benefits and 401K
• 19 days of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment

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 customers and 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 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 [email protected]. 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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