Catalent Pharma Solutions Computer Systems Validation Lead in Kansas City, Missouri
Computer Systems Validation Lead
CSV Lead is responsible for establishing, maintaining and performing processes and procedures for Computer System Validation (CSV) and System Administration of computerized GMP Systems in use at the Kansas City site, with emphasis on:
Computerized GMP systems Inventory
Development, maintenance and execution of CSV
Client and Regulatory Inspection Support
Ongoing validated state of systems
This role will ensure the application of modern CSV and compliance requirements applicable to computerized systems supporting site GMP operations in alignment with Global Catalent policies.
The role will interface with site Management, Operations, Quality, Metrology and Facilities functions as well as with global Quality and IT functions to ensure the ongoing validated state of GMP systems. This role will also interface with customers and regulatory authorities in support of ongoing operations and inspections.
Specific Duties, Activities, and Responsibilities:
Act as the Data Integrity, CSV and regulatory compliance site contact and subject matter expert.
Manage the site Data Integrity and other systems compliance programs in collaboration with global quality.
Develop and maintain an Inventory of computerized GMP systems in compliance with global Catalent requirements.
Perform or provide oversight of Computer System Validation for site GMP Systems including system assessments, the generation of CSV Documentation and validation testing in compliance with and adherence to global CSV policies and procedures.
Education or Equivalent:
BA, BSc or equivalent experience in Computer Systems Validation (CSV). Educational qualification(s) associated with engineering, information technology and/or pharmaceutical science would be an advantage.
Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance.
Strong knowledge and experience with the Windows Office Suite.
Working knowledge of Project Management and system implementations/integrations.
Familiarity with computer infrastructure, servers, workstations and operating systems.
Familiarity with computerized pharmaceutical GMP application and equipment systems, especially Packaging, Labeling and Logistics systems and their associated vendors.
Preferred understanding of serialization
Clear understanding of data integrity issues associated with CSV systems
Physical and Personal Requirements:
Ability to work effectively under pressure and comply with timelines.
Specific vision requirements include reading written documents and computer monitor use.
Ability to develop strategic relationships; strong verbal and written communication skills; good presentation skills.
Creative and Innovative with proven communication skills both written and verbal
We will identify candidates based on the following:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision and 401K
19 days of paid time off annually + 7 paid holidays
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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at
+1 877 503 9493.
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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.