Senior Engineer, Validation

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

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.

Position Summary

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

The Role

• 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.

Candidate Minimum Requirements

• 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.

Preferred Skills & Background

• Blue Mountain experience.
• TrackWise experience.
• Audit and inspection support.
• Mentoring or lead-level experience.

Pay

The anticipated salary range for this position in MD is $120,000 – $140,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Equal Employment Opportunity

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Company Overview

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.