Senior CSV Engineer

Senior Validation Engineer

Position Summary

The Senior CSV Validation Engineer is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities include coordinating multiple projects, documenting activities via protocols and summary reports. This role will help establish validation strategies and policies, as needed, including reviewing facilities changes and providing input on re-validation, assessing risks involved in processing steps related to equipment, facility/utility and computer systems validation. This role will help develop and/or review validation requirements and design deliverables.

The Role

• Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
• Author and Review of Validation Deliverables - Validation Master Plan (VMP), System Impact Assessment, Detailed Risk Assessment, User Requirement Specification Document, Functional Specification/Design Specification Document, Configuration Specification document, 21 CFR Part 11 Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports.
• Review and Provide guidance on Deviations/Defects during the IOQ/PQ executions.
• Leads all aspects of validation efforts relating to computer systems.
• Ensure site systems are compliant with the corporate Data Integrity program.
• Authored and Reviewed Data Integrity Assessments and Remediation plans.
• Participates in activities related to validation including design, maintenance, and change control.
• Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance.
• Tracks and communicates project status, as well as project risks and recommendations to stakeholders.
• Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible for maintaining computer systems and software in a valid state.
• Provide input into Requirements Specifications for new equipment at the facility
• Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations
• Collaborates with other team members to ensure goals and objectives are achieved.
• Author, Review and approve Standard Operating Procedures (SOPs)

The Candidate

• Bachelor's degree in a Science or Engineering field with 5 years of experience preferred or similar experience highly desirable.
• In lieu of a Bachelor's degree, an Associate's degree with 6+years of experience preferred
• Master's degree in a Science or Engineering field with 2-3 years of experience preferred or similar experience highly desirable
• Able to work in a team setting and independently under minimum supervision.
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Experience with Commissioning and Qualification activities for Drug Substance and Fill/Finish

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.

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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 [email protected]. 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.

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