Specialist, QA Validation & Engineering

Position Summary We have an opportunity for a Specialist, QA Validation & Engineering to join our team at Catalent’s Baltimore site. In this role you will provide quality oversight for Facilities, Engineering, and Validation groups to ensure compliance with regulations and company policies, support continuous improvement for processes, equipment, utilities, and systems, and serve as a key quality resource for commercial GMP manufacturing of biological drug substances and products. Responsibilities Serve as the QA liaison with Facility, Engineering, and Validation teams to support company goals, client projects, and continuous improvement initiatives. Review and approve protocols and summary reports for process validation such as PPQs, engineering studies, and cleaning validation. Review and approve equipment qualification protocols such as Installation Qualification, Operational Qualification, and Performance Qualification for equipment including bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves, and critical utilities. Support review of the Validation Master Plan. Provide QA support to the calibration program, including review and approval of calibration plans, completed calibrations, and compliance with schedules. Provide QA support for the maintenance program, including review and approval of preventive maintenance plans and procedures to ensure suitability for intended use. Review corrective maintenance work orders. Review and approve deviations and assist in investigations and root cause analysis for equipment and utility failures. Support the facility and equipment change management program by reviewing change controls to ensure proper activities and documentation. Participate in site and corporate quality and process improvement initiatives. Support client and regulatory audits. Qualifications Bachelor’s degree in a scientific, engineering, or biotech field with 3 years of experience in the biologic, pharmaceutical, or medical device industry performing hands‑on work in a quality assurance function, OR an Associate’s degree in a scientific, engineering, or biotech field with 5 years of such experience. Knowledge of Good Manufacturing Practices, 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs. Good understanding of upstream and downstream manufacturing processes. Preferred experience performing or supporting validations associated with Installation Qualification, Operational Qualification, and Performance Qualification for controlled temperature units such as freezers, refrigerators, incubators, autoclaves, and biologics manufacturing equipment. Experience with facility expansion and aseptic processing. Experience in reviewing and writing deviations and investigations. Pay The anticipated salary range for this position in MD is $70,000 – $90,000, plus bonus. The final salary offered may vary based on factors such as experience, education, and business needs. Benefits Diverse and inclusive culture. Defined career path with annual performance reviews and feedback. Competitive paid time off and 8 paid holidays. Community engagement and green initiatives. Medical, dental, and vision benefits effective on day one. Tuition reimbursement. Equal Opportunity Employer 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, please email View email address on click.appcast.io with the job number, title, and location. #J-18808-Ljbffr Catalent Pharma Solutions