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

　　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 policies, SOPs and/or protocols

　　Participate in cross-functional meetings to help coordinate commissioning and qualification for new facility expansion and construction projects including fill/finish equipment and drug substance manufacturing equipment

　　Collaborate with Manufacturing, MS&T, Engineering and QA to develop CQV strategies which include commissioning, qualification and validation

　　Perform validation testing and analyze data for validation documentation to determine acceptability, identify discrepancies and make appropriate notifications

　　Assist with updating/maintaining the site validation master plan and integrated commissioning and qualification plans for facility expansions

　　Support internal, regulatory and client audits for Validation

　　Organize, schedule and track validation projects in order to meet client requirements/timelines

　　Generate and modify validation procedures/work instructions for GMP equipment

　　Lead and participate in the initial onboarding client deliverables (i.e. scheduling, assessment training, documentation execution, issue resolution, reporting, etc.)

　　Maintain the validated status of manufacturing equipment

　　Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidances.

　　Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations

　　The Candidate

　　Bachelor’s degree in a Science or Engineering field with 2+ years of experience preferred or similar experience highly desirable.

　　In lieu of a Bachelor’s degree, an Associate’s degree with 5+years of experience preferred

　　Knowledge of FDA Qualification guidelines and cGMPs relavant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines

　　Experience performing/supporting equipment qualification in a cGMP environment such as Autoclaves, Refrigerators, Freezers, Incubators, Bioreactors, Chromatography Systems, Tangential Flow Filtration (TFF) Systems, Analytical Equipment.

　　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 Facility Expansion and Computer Systems Validation are a plus

　　Catalent 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

　　152 hours of paid time off annually + 8 paid holidays

　　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.

　　Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

　　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.

　　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.

　　Important Security Notice to U.S. Job Seekers:

　　Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

　　California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .