About Site
Catalent’s Baltimore site is a leading facility specializing in biologics development and manufacturing, offering state-of-the-art capabilities for clinical and commercial supply. The campus provides an advanced environment where teams collaborate on innovative solutions to support life-changing therapies. With a strong focus on quality and scientific excellence, the site fosters a dynamic and supportive workplace that values expertise and continuous improvement. Employees here are part of a mission-driven culture dedicated to delivering critical treatments to patients worldwide, making it an inspiring place to grow your career in the biopharmaceutical industry.
Position Summary
We have an opportunity for a Specialist, QA Validation & Engineering to join our team. In this role, you will provide quality oversight for Facilities, Engineering, and Validation groups to ensure compliance with regulations and company policies. You will support continuous improvement for processes, equipment, utilities, and systems while serving as a key quality resource. This position plays a critical role in supporting commercial GMP manufacturing of biological drug substances and products.
Shift: Monday - Friday 8am-5pm
Location: Harmans, MD - BWI
100% Onsite
The Role
- 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.
The Candidate
Minimum Requirements
- 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 Skills & Background
- 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.
