Specialist, QA Validation & Engineering

Specialist, QA Validation & Engineering About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. Position Summary We have an opportunity for a Specialist, QA Validation & Engineering to join our team. In this role, you will provide Quality oversight of Facilities, Engineering, and Validation groups to ensure compliance with US regulations, industry standards, and internal policies. You will support continuous improvement for processes, equipment, utilities, and computer systems. This position serves as a key Quality resource for Engineering, Facilities, and Validation organizations. Shift: Monday - Friday 8am-5pm Location: Harmans, MD - BWI 100% Onsite The Role Act as Quality Assurance representative for review and approval of process validation lifecycle documents, including Validation Master Plans, Process Performance Qualification protocols and reports, engineering and characterization studies, and Continued Process Verification documentation. Provide QA oversight throughout the process validation lifecycle to ensure compliance with regulatory requirements, industry standards, and internal procedures. Support cleaning validation programs through protocol and report review and approval. Collaborate with Manufacturing, Process Development, Validation, Engineering, and Technical Services teams to support process validation programs and continuous improvement initiatives. Review and approve deviations, investigations, corrective and preventive actions, and risk assessments related to process validation activities. Review and approve change controls impacting validated manufacturing processes, ensuring proper assessments, implementation plans, and supporting validation documentation. Support client, regulatory, and internal audits by providing subject matter expertise on process validation programs and quality systems. Support QA review of qualification activities for manufacturing equipment, process equipment, cleanrooms, facilities, and GMP utilities. Review and approve calibration and preventive maintenance documentation to ensure continued suitability of validated systems and equipment. Perform additional duties as assigned by the manager. The Candidate Minimum Requirements Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related scientific discipline. Minimum 1-3 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment. Experience reviewing and approving process validation documents, including Process Performance Qualification protocols and reports. Strong knowledge of FDA, EMA, ICH, and current Good Manufacturing Practice requirements applicable to process validation. Experience with deviation management, investigations, corrective and preventive actions, risk assessments, and change control systems. Preferred Skills & Background Experience supporting equipment qualification (Installation Qualification, Operational Qualification, Performance Qualification). Experience with facility and utility qualification. Experience with cleaning validation and computerized systems validation. Familiarity with biologics, cell therapy, gene therapy, plasmid manufacturing, or sterile manufacturing processes. Pay The anticipated salary range for this position in MD is $70,000 – $90,000 Plus Bonus. 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 states. Why You Should Join Catalent Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive paid time off plus 8 paid holidays Community engagement and green initiatives Medical, dental and vision benefits effective day one of employment Tuition Reimbursement 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 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 . 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. 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Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.