Senior Validation Engineer – GMP Compliance & Impact

Regulatory Jobs; Harmans (MD); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

Paid time off

Job summary

Catalent is seeking a Senior Engineer, Validation to lead the planning, execution, and documentation of validation projects at our Harmans, MD site. You will provide expert oversight for qualification of equipment, utilities, facilities, and computerized systems throughout the product lifecycle.

You will mentor junior staff, support GMP compliance and inspections, and drive continuous improvement within the site validation program. Onsite work from Monday to Friday is required.

Qualifications

• Hands‑on validation experience in a GMP-regulated environment.
• Knowledge of equipment, utilities and facilities qualification.
• Experience authoring and executing validation documents (IQ/OQ/PQ), risk assessments and traceability matrices.

Responsibilities

• Lead and execute validation projects for equipment, utilities, facilities, and computerized systems.
• Write, review, and approve validation documents including IQ, OQ, PQ protocols and related reports.
• Manage Computerized System Validation activities to ensure regulatory compliance.
• Review change controls, deviations, CAPAs, and perform validation impact assessments.
• Coordinate with Engineering, Quality, Manufacturing, Metrology, and 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 drive continuous improvement.

Skills

Validation experience

GMP experience

IQ/OQ/PQ docs

Technical writing

On-site work

Education

Bachelor's degree in Engineering

Master’s degree in Engineering or Science

Tools

TrackWise

Job description

Catalent is seeking a Senior Engineer, Validation to lead the planning, execution, and documentation of validation projects at our Harmans, MD site. You will provide expert oversight for qualification of equipment, utilities, facilities, and computerized systems throughout the product lifecycle.

You will mentor junior staff, support GMP compliance and inspections, and drive continuous improvement within the site validation program. Onsite work from Monday to Friday is required.