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Senior Computer Systems Validation Engineer

Company: Catalent Pharma Solutions
Location: Rockville
Posted on: May 1, 2021

Job Description:

Job DescriptionPosition Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalents 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 ( The Senior Computer Systems Validation Engineer will work in an FDA regulated clean room environments and laboratories. This position is responsible for all Computer Systems Validation activities at the Gaithersburg and Rockville sites. The candidate will be responsible for ensuring site compliance to 21 CFR Part 11, and Annex 11. The candidate will also ensure Data Integrity requirements are met in accordance with corporate compliance strategies.Catalent Cell and Gene Therapy 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.The Role + Support computerized system validation and data integrity initiatives and projects by writing and executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.+ Author final reports summarizing execution of computerized system validation protocols and support documents (amendments, repeat test forms, addenda and deviations).+ Interface with Validation, Quality Assurance, Engineering, IT, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.+ Interface with regulatory authorities and partners as the SME for the computerized system validation program+ May also develop Validation Master Plans, Validation Project Plans and Project Schedules as needed. + May interact with internal clients and external vendors on CSV requirements. + Support changes through the provision of necessary validation documentation and change control activities. + Support the regulatory defense of CSV protocols and summary reports during audits and internal audits. + Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures. Collect and analyze data to make data driven recommendations/decisions The Candidate + B.S. in Engineering, Computer Systems Engineering, or IT/IS related field + Minimum of 5-7 years of experience in biopharma manufacturing or GMP Environment Catalents standard leadership competencies that are used to interview and for Performance & Development+ Leads with Integrity and Respect+ Delivers Results+ Demonstrates Business Acumen+ Fosters Collaboration and Teamwork+ Champions Change+ Engages and Inspires+ Coaches and DevelopsPosition Benefits+ Potential for career growth within an expanding team+ Defined career path and annual performance review & feedback process+ Cross functional exposure to other areas of within the organization + Medical, Dental, Vision, and 401K are all offered from day one of employment+ 19 days of paid time off annually + 8 paid holidaysCatalent 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 everyones safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit 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 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.Catalent = Catalyst + TalentYour 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 ( .

Keywords: Catalent Pharma Solutions, Rockville , Senior Computer Systems Validation Engineer, IT / Software / Systems , Rockville, Maryland

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