Senior Engineer, Validation

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.

We have an opportunity for a Senior Engineer, Validation to join our team. This role leads the planning, execution, and documentation of validation projects to ensure compliance with regulatory requirements and internal quality standards. The position provides technical expertise and oversight for the qualification of equipment, utilities, facilities, and computerized systems across the product lifecycle. The Senior Engineer, Validation acts as a subject matter expert and key contributor in cross-functional teams, ensuring GMP compliance, inspection readiness, and operational excellence while mentoring junior staff and supporting continuous improvement initiatives.

Shift : M-F 8am-5pm
Location
:
Harmans, MD - BWI
100% Onsite

• Lead and execute validation projects for equipment, utilities, facilities, and computerized systems.
• Write, review, and approve validation documents including Installation Qualification, Operational Qualification, and Performance Qualification protocols, reports, risk assessments, and traceability matrices.
• Manage Computerized System Validation activities to ensure regulatory compliance.
• Review change controls, deviations, and Corrective and Preventive Actions, and perform validation impact assessments.
• Coordinate with Engineering, Quality, Manufacturing, Metrology, and external vendors.
• Support equipment requalification and periodic review programs.
• Participate in audits and regulatory inspections and provide validation documentation.
• Troubleshoot validation issues and develop risk-based solutions.
• Mentor junior validation engineers and provide technical guidance.
• Drive continuous improvement initiatives within the site validation program.

• Bachelor’s degree in Engineering, Life Sciences, or related scientific field plus 5+ years of validation experience; or Master’s degree in Engineering or Science plus 3+ years of validation experience.
• Direct hands-on validation experience in a pharmaceutical, biotech, or other Good Manufacturing Practice-regulated environment.
• Experience with equipment, utilities, and facilities qualification.
• Experience authoring and executing validation documents such as Installation Qualification, Operational Qualification, Performance Qualification, protocols, reports, risk assessments, and traceability matrices.
• Knowledge of current Good Manufacturing Practice, Food and Drug Administration regulations, Good Automated Manufacturing Practice 5, 21 Code of Federal Regulations Part 11, and Annex 11.
• Experience with Computerized System Validation.
• Strong technical writing, problem-solving, and cross-functional communication skills.
• Ability to work on-site and support cleanroom and Good Manufacturing Practice operations as needed.

• Blue Mountain experience.
• Track Wise experience.
• Audit…