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Computer System Validation Specialist

Catalent Pharma

This is a Contract position in Bridgewater Township, NJ posted September 12, 2020.

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 Position Summary The Computer System Validation Specialist reports to Sr.

Manager Validation and Calibration.

Our Somerset location is the corporate headquarters for Catalent Pharma Solutions.

This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.

The Role Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the GAMP5 Validation Life Cycle; Documents includes like Data Integrity Assessment, FDA 21CFR Part 11 and EU GMP Annex 11 Assessment, Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review; Ensure that site Computer System Inventory list is maintained per corporate format and remain in current state; As a Subject Matter Expert (SME), Computer System Validation Engineer/Specialist should be a site computer system administrator for equipment and instrument computer systems; Generate validation protocols in line with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations; Generate a CSV validation plan detailing the scope of work and intent.

• Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements; Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business) procedures and EHS requirements; Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations; Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.

Prepare validation summary reports for executed protocols; Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments; Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures; The Candidate Requires a Bachelors or Masters Degree in Computer/Electrical Engineering or other relevant Science Field; Prefers 5-7 years of experience in a CGMP-related industry with at least 3-4 years of experience with Computer System Validation experience working with cGMP pharmaceutical/nutraceutical regulated industries and 21 CFR Part 11 compliance; Preferred validation experience in the following areas will be considered plus: Equipment/Instrument Qualification, Cleaning Validation, and Process Validation, Code of Federal Regulations and CGMP’s relating to the field of Computer System Validation; Prefers in depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines; Prefers experience with the following applications/systems is preferred: Wonderware/OSI-PI (or other similar systems), WinCC, Allen Bradley PLCs/equipment (RSView, PanelView, RSLogix), ladder logic programming; Position Benefits Opportunity to work with a growing department with high visibility to Senior Leadership 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 DisabilityAccommodationscatalent.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.