Senior Validation Engineer — GMP & CS (Onsite)

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

Benefits offered by this job

Medical, dental, vision benefits

Tuition Reimbursement

8 paid holidays

Job summary

Catalent in Harmans, MD is hiring a Senior Engineer, Validation to lead validation of equipment, utilities, facilities, and computerized systems. You will author IQ/OQ/PQ, risk assessments, and traceability matrices while ensuring GMP compliance and inspection readiness.

The role requires on-site work, cross-functional coordination, and mentoring junior engineers to drive continuous improvement within the site validation program. Competitive salary with bonus potential and comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field with 5+ years of validation experience (or Master’s with 3+ years).
• Direct hands-on validation experience in pharmaceutical/biotech or GMP-regulated environments.
• Experience with equipment, utilities, and facilities qualification.
• Experience authoring/ executing IQ, OQ, PQ, reports, risk assessments, and traceability matrices.
• Knowledge of GMP, FDA regulations, 21 CFR Part 11, Annex 11, and cGMP.
• Experience with Computerized System Validation.
• Strong technical writing, problem-solving, and cross-functional communication skills.
• Ability to work on-site and support cleanroom/GMP operations.

Responsibilities

• Lead and execute validation projects for equipment, utilities, facilities, and computerized systems.
• Write, review, and approve IQ/OQ/PQ protocols, reports, risk assessments, and traceability matrices.
• Manage Computerized System Validation activities for regulatory compliance.
• Review change controls, deviations, and CAPAs; 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 within the site validation program.

Skills

Validation leadership

Cross-functional communication

Technical writing

GMP compliance

Education

Bachelor's degree in Engineering or Life Sciences

Master’s degree in Engineering or Science

Tools

TrackWise

Job description

Catalent in Harmans, MD is hiring a Senior Engineer, Validation to lead validation of equipment, utilities, facilities, and computerized systems. You will author IQ/OQ/PQ, risk assessments, and traceability matrices while ensuring GMP compliance and inspection readiness.

The role requires on-site work, cross-functional coordination, and mentoring junior engineers to drive continuous improvement within the site validation program. Competitive salary with bonus potential and comprehensive benefits.