Data Integrity and Technology Leader

Catalent

Morrisville,NC  

2019-10-13 2019-11-12
pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

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











This position will report directly to the Manager, Validation and Operations Technology



Overview



The Operations Technology group is part of the Validation and Technology branch of the Quality Assurance organization at the Morrisville RTP location. Validation and Technology includes the Validation department and the newly formed Operations Technology group. The Operations Technology group will serve as application specialists that will be responsible for implementing corporate-based computerized systems, supporting the use and administration of site-based systems within laboratories, and clinical and commercial manufacturing spaces, and will serve as the site’s data integrity experts to identify and remediate legacy computerized systems.







The Group Leader of Operations Technology would be responsible for overseeing personnel responsible for implementing and administration of computerized systems used within Catalent’s GMP laboratory operations, commercial and clinical manufacturing areas, and supporting facility, utility, and IT areas.



Further, this position will be responsible for ensuring the team carries out the duties as described within the administrative procedures.







In addition to supporting compliance of electronic and analytical systems this position will have responsibility for managing the site based support staff for analytical systems. This individual would manage and support individuals that serve as Laboratory System Administrators (LSAs) for the Empower 3 Chromatography Data Collection System (CDS) and for other critical laboratory automation and information management systems such as LIMS and an Electronic notebook system (ELN).







The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.







The Role





+ Lead and manage team of FTEs and contractors responsible for addressing data integrity remediation tasks and LSAs for critical laboratory automation and information management systems.



+ Provide technical ownership/oversight for the implementation, upgrade, and support of site based application systems, such as; client-driven instruments, desktop GxP applications, and computerized equipment.



+ Review and approve documentation associated with computerized systems



+ Create and maintain schedule for User access and audit trail reviews



+ Manage Data Integrity related actions for all computerized systems



+ Administration and support for systems including:



+ Adding/removing users



+ Performing user access reviews and audit trail reviews



+ Troubleshooting and problem resolution



+ Change and configuration management



+ Maintenance of system setup and master data







+ Assist with the development, execution and approval of System and Validation Lifecycle Documentation for site GxP systems.









The Candidate





+ Bachelors of Science in IT, OT, or other scientific/technical related discipline



+ 10+ years’ experience in pharmaceutical/biotech environment, with focus in computer system administration, validation, laboratory operations, IT, or quality assurance.



+ Experience in leading the technical implementation of new or upgraded GxP computerized systems in laboratory or manufacturing areas.



+ 3+ years’ managing direct reports and/or contractors.









Position Benefits





+ Potential for career growth within an expanding department as well as other areas



+ Medical, Dental, Vision and 401K are all offered from day one of employment



+ 19 days of paid time off annually + 7 paid holidays









Leadership Competencies for Performance and Development





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









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 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





Catalent = Catalyst + Talent







Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!







personal initiative. dynamic pace. meaningful work.







Catalent is the perfect place to grow your career if…





+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).











+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!











+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.











+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.











+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!











+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.











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.
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