The Validation Engineer will work in an FDA regulated clean room environment, this position is responsible for validation of bio process equipment and GMP utilities. We are seeking a candidate with experience in commissioning of a new facility with a hands-on approach to working with others to accomplish goals and objectives. This position will report to the Equipment Validation Manager.

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?

THE ROLE:

• Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility.

• Project based work will be in 3 main areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS)

• May also develop Validation Master Plans, Validation Project Plans and Project Schedules as needed

• Oversees the timely completion of all validation documentation, including coordination of contractor activities.

• May interact with internal clients and external vendors on equipment/process requirements.

• Support the maintenance of the validation program for facilities and equipment.

• Support changes through the provision of necessary validation documentation and change control activities.

• Support the regulatory defense of validation protocols and summary reports during audits and internal audits.

• Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems

• 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.

• Participate in equipment failure investigations.

• Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality, Facilities and Engineering.

• Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies

• Generates, reviews, and approves qualification protocol(s), for various processes in the facility.

• Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.

• Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.

• Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.

• Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.

• Support the validation program for process qualification, aseptic processing, and cleaning verification activities.

• Provide SME level support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures.

• Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.

• Support the Process Validation, CSV, Fill and Finish teams as needed

THE CANDIDATE:

• Bachelor or Master’s degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering.

• 1-5 years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities

• Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable

• Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe)

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 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 DisabilityAccommodations@catalent.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.

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 spam@catalent.com for us to investigate with local authorities.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.