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Validation Engineer for Equipment

2 months ago

Severn, Maryland, United States Catalent Full time

Equipment Validation Engineer

Position Overview:

Catalent is a prominent, rapidly expanding public organization and a key collaborator for the pharmaceutical sector in the creation and production of innovative therapies for patients globally. Your skills, insights, and enthusiasm are vital to our mission: to enhance the quality of life for individuals.

Catalent Cell & Gene Therapy is an evolving Contract Development and Manufacturing Organization (CDMO) with a globally acknowledged legacy of excellence and service. Catalent offers process development and GMP manufacturing solutions for Phase I/II clinical trials to industry frontrunners as well as pioneering start-ups employing novel technologies to create cutting-edge vaccines and therapies for individuals in critical need. As a member of Catalent, you will play an active role in delivering our services and products to our clients and their patients.

Catalent Pharma Solutions is seeking an Equipment Validation Engineer who will operate in a clean room environment regulated by the FDA. This role entails the validation of bioprocess equipment and GMP utilities. We are looking for a candidate with a hands-on approach and experience in the commissioning of new facilities, collaborating effectively with others to achieve objectives.

This is a full-time, salaried position. The core working hours are Monday – Friday, 9:00 AM - 5:00 PM.

Catalent is dedicated to a Patient First culture, emphasizing excellence in quality and compliance, and ensuring the safety of every patient, consumer, and Catalent employee.

Responsibilities

Develops operational protocols, qualification IQ, OQ, PQ protocols, and SOPs for various equipment/systems/processes within the facility; Project-based work will focus on three primary areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS); May also create Validation Master Plans, Validation Project Plans, and Project Schedules as necessary; Ensures the timely completion of all validation documentation, including coordination of contractor activities; Supports the maintenance of the validation program for facilities and equipment; Aids in the regulatory defense of validation protocols and summary reports during audits and internal reviews; Develops and promotes continuous improvement initiatives for the validation of equipment, facilities, utilities, and control systems; Provides hands-on support to manufacturing areas as needed to assist in problem-solving and implementing long-term changes that enhance product/process efficiency in relation to equipment failures; collects and analyzes data to make informed recommendations; Supports the validation program for process qualification, aseptic processing, and cleaning verification activities; Offers subject matter expert (SME) level support to manufacturing areas as required to assist in problem-solving and long-term changes that enhance product/process efficiency in relation to process failures; Performs other duties as assigned;

Qualifications

Bachelor’s or Master’s degree in Life Science or Engineering, preferably in Chemical/Biochemical Engineering; Minimum of 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 preferred; Familiarity with Kaye datalogging equipment (Validator, AVS, ValProbe); Ability to sit, stand, and walk regularly, with occasional lifting of 0-15 pounds;

Why Catalent?

Clearly defined career progression and annual performance review process; A diverse and inclusive workplace culture; A positive work environment focused on continuous process improvement and innovation; Opportunities for career advancement within a growing team dedicated to enhancing lives; Generous time off policies including 152 hours plus 8 paid holidays; Various Employee Resource Groups emphasizing diversity and inclusion; A dynamic and fast-paced work environment; Community engagement and sustainability initiatives; Competitive 401K matching; Company matching for donations to charitable organizations; Comprehensive medical, dental, and vision benefits effective from the first day of employment; Tuition reimbursement to support your educational goals; WellHub program promoting overall physical wellness; Perkspot offering exclusive discounts from numerous merchants across various categories;

Catalent provides rewarding opportunities to advance your career Join a global leader in drug development and delivery and contribute to bringing life-saving and life-enhancing products to patients worldwide. Catalent is an exciting and expanding international organization where employees collaborate directly with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to advance new medicines from early development through clinical trials to market. Catalent produces over 70 billion doses annually, each of which will be utilized by someone relying on us. Together, we can make a significant impact.

Catalent prioritizes the health and safety of its employees, visitors, and the customers and patients we serve. In response to the global pandemic, we have adapted many of our recruitment and onboarding processes to ensure everyone's safety. The Human Resources teams will communicate all necessary safety protocols throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit our careers page to explore opportunities.

Catalent is an Equal Opportunity Employer, including individuals with disabilities and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request through the appropriate channels. This option is reserved for individuals needing accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and routed to a local recruiter who will assist in ensuring appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to any Catalent employee by a third-party agency without a valid written and 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 requests 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 report such requests for investigation.

California Job Seekers can find our California Job Applicant Notice.