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Computer Systems Validation Engineer - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025
Computer Systems Validation Engineer Position Summary:Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients.Catalent Pharma Solutions in Harmans, MD is hiring an Engineer, CSV who 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.This is a full-time, salaried role.-- This is onsite. Remote or hybrid is not available. The core hours are Monday - Friday 8:00AM - 5:00PM.Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--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;
- Identify data integrity risks and propose improvement 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, GxP and applicable FDA/EMA Guidance;
- Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible for maintaining computer systems and software in a valid state;
- Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations;
- All other duties as assigned;The Candidate
- Bachelor's degree in Science or Engineering field with a minimum of two (2) years of direct engineering experience required;
- Able to work in a team setting and independently under minimum supervision;
- Knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks;
- Demonstrated experience with CSV Commissioning and Qualification activities in a regulated industry required. Exposure and relatable experience will be considered;
- Knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;The Pay
- The anticipated salary range for this position in Maryland is $74,080,000 - $101,000 plus annual bonus when eligible.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other statesWhy you should join Catalent:
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