What are the responsibilities and job description for the CSV, Manager position at Catalent?
The Computer Validation Manager will develop, maintain, and improve upon Catalent Computer Software Validation (CSV) strategies by establishing/improving policies and procedures that govern our approach to the overall CSV effort, with the goal of assuring CSV compliance at all company sites. The Manager will direct a team and oversee qualifying equipment both in the and outside of the lab and the enterprise systems that run them.
Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.
- Develop CSV operational strategies by establishing governing policies/procedures.
- Generation/oversight of CSV Validation Master Plans for all Catalent manufacturing sites.
- Management of CSV projects at both sites, including the oversight of CSV projects and contractors.
- Serve as the Validation point of contact for all CSV projects/activities.
- Actively participate in the selection process of all new eSolutions introduced at Catalent sites, engaging the projects at an early stage of the process to ensure CSV compliance.
- Generation or oversight of CSV protocols for enterprise-level, manufacturing and laboratory systems.
- Serve as CSV SME for all client-related issues/concerns dealing with CFR Part 11 compliance and data integrity.
- Provide supervision of Catalent CSV Validation Engineers.
The Candidate:
- Bachelor’s degree in engineering, science; Master’s preferred
- 10-15 years’ experience in a management validation role with responsibility for computer validation
- 5 years leadership both in developing high performing teams but also leading projects
- Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications, with a focus on 21 CFR Part 11, 21 CFR Parts 210/211, and GAMP 5.
- Knowledgeable of FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle.
- Experience in the validation of cloud base enterprise systems (Enterprise resource planning, LIMS, Doc Management, training, Environmental monitoring systems, and Data Management systems is strongly preferred.
- Knowledge of quality business practices and business development.
- Excellent multi-tasking, analytical, organizational and leadership skills.
- Ability to troubleshoot, identify root cause and systematically resolve problems.
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 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.
