Equipment Validation Engineer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

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 a Equipment Validation Engineer who 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 is a full-time, salaried role. This is onsite. The core hours are Monday – Friday 9:00AM -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

• 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;

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

• 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;

• 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;

• All other duties as assigned;

The Candidate

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

• 2+ 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);

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 Hours + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Company match on donations to organizations

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement – Let us help you finish your degree or start a new degree!

• WellHub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 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 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.

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) .