Senior Validation Engineer — GMP Systems & Equipment Lead

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Defined career path

Diverse culture

Medical dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking a Senior Engineer, Validation to lead the planning, execution, and documentation of validation projects across equipment, utilities, facilities, and computerized systems. You will ensure GMP compliance, inspection readiness, and collaboration with cross-functional teams.

The role requires a Bachelor’s or Master’s in a related field with 3–5+ years of validation experience, hands-on IQ/OQ/PQ work, and knowledge of FDA/GA GMP regulations.

Qualifications

• Bachelor’s degree plus 5+ years validation in a regulated environment.
• Hands-on validation experience with equipment, utilities, facilities qualification.
• Experience authoring/executing validation documents (IQ/OQ/PQ, risk assessments, traceability matrices).
• Knowledge of GMP, FDA regs, 21 CFR Part 11, and Annex 11.

Responsibilities

• Lead validation projects for equipment, utilities, facilities, and computerized systems.
• Write, review, and approve IQ/OQ/PQ protocols, reports, and risk assessments.
• Manage Computerized System Validation activities for regulatory compliance.
• Coordinate with Engineering, Quality, Manufacturing, Metrology and vendors.

Skills

Technical writing

Problem-solving

Cross-functional collaboration

On-site availability

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s degree in Engineering or Science

Tools

TrackWise

Validation documentation tools

Computerized System Validation

Job description

Catalent Pharma Solutions in Harmans, MD is seeking a Senior Engineer, Validation to lead the planning, execution, and documentation of validation projects across equipment, utilities, facilities, and computerized systems. You will ensure GMP compliance, inspection readiness, and collaboration with cross-functional teams.

The role requires a Bachelor’s or Master’s in a related field with 3–5+ years of validation experience, hands-on IQ/OQ/PQ work, and knowledge of FDA/GA GMP regulations.