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.

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