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Associate Director, Validation & Engineering

Catalent Pharma Solutions is looking to hire a **Associate Director, Validation & Engineering** to lead our Equipment Validation, Metrology, and Engineering departments in Maryland.

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.

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 (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . 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.

The **Associate Director, Validation & Engineering** is responsible for the strategic leadership and management of the site Equipment Validation, Metrology, and Engineering departments. This leader is accountable for overseeing a team focused on equipment readiness for clinical campaigns of biopharmaceutical products at our development and manufacturing sites. This includes supporting commercial manufacturing equipment (Drug Substance/Drug Product) and establishing validation policies and strategies that align with Catalent’s quality standards, FDA/EMA requirements, and industry best practices.

This position plays a pivotal leadership role in driving operational excellence, regulatory compliance, and cross-functional collaboration. Key performance indicators include clinical campaign readiness performance to plan, equipment reliability/uptime, corrective action % on-time completion, quality event % on-time completion, employee engagement and retention, regulatory compliance, and client net promoter score.

This leader will foster a culture of accountability, innovation, and continuous improvement while mentoring, developing, and inspiring a high-performing team.

The Associate Director, Validation & Engineering will report to the Senior Director, Operations.

The Supervisors of Engineering, Validation, Engineering Technician and Metrology will report to the Associate Director, Validation & Engineering.

This is a full-time onsite position working Days; Monday – Friday, 8am-5pm and the position will provide support for both the BWI sites and BioPark.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

+ Lead and mentor teams across Validation, Engineering, and Metrology, fostering expertise in qualification, calibration, and maintenance of bioprocess equipment.

+ Develop departmental strategies aligned with corporate and site objectives, ensuring regulatory compliance with FDA, EMA, and cGMP standards.

+ Cultivate a culture of ownership, technical excellence, and continuous improvement in equipment validation, metrology, and automation systems.

+ Contribute to site leadership, strategic planning, and capital project prioritization, optimizing biomanufacturing and process engineering efforts.

+ Oversee resource planning, talent development, and succession planning within engineering functions, maintaining operational continuity.

+ Champion safety, quality, and compliance while ensuring adherence to 21 CFR Part 11, Eudralex Annex 11, and electronic data integrity requirements.

+ Lead validation and engineering projects, including IQ/OQ/PQ execution for bioreactors, centrifuges, chromatography systems, controlled temperature units, and cleanroom environments.

+ Act as SME on bioprocess equipment, troubleshooting and repairing automated systems such as TFF, chromatography columns, and fill lines.

+ Analyze and develop engineering solutions for maintenance, continuous improvement, failure investigations, and CAPA implementation.

+ Manage validation lifecycle, ensuring compliance with regulatory expectations and maintaining requalification/periodic review programs for critical equipment.

+ Support facility and equipment change management via risk assessments using FMEA, Fault Tree Analysis, and validation impact evaluations.

+ Oversee computerized maintenance management systems (CMMS) and electronic quality systems for asset management, change control, and documentation.

+ Provide validation expertise for site expansion projects, including commissioning and qualification of HVAC, Process Gases, Water for Injection (WFI), and automation systems.

+ Other duties as assigned

The Candidate

+ Bachelor’s degree in a Science or Engineering field with 9+years of industry experience preferred (additional experience may be substituted for education, as appropriate)

+ 5 or more years related work experience (GMP / Bio-Pharma maintenance/ engineering).

+ Minimum 4 years of progressive leadership experience, including performance management and people development.

+ In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation, USP Guidelines, ICH Guidelines, and ISPE GAMP guidelines. EMA guidelines preferred.

+ Experience performing/supporting validations associated to IQ, OQ & PQ for Facility/Utility, Drug Substance (Upstream and Downstream) and Drug Product (aseptic fill/finish).

+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

+ Able to work in a team setting and independently under minimum supervision, and have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.

+ Exhibit strong technical writing ability to clearly and effectively communicate technical ideas and concepts.

The anticipated salary range for this position in Maryland is $160,000 to $210,000 plus an annual bonus, when eligible.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

+ Potential for career growth within an expanding team.

+ Defined career path and annual performance review & feedback process.

+ Cross-functional exposure to other areas within the organization.

+ Medical, Dental, Vision, and 401K are all offered from day one of employment.

+ 152 hours of PTO and 8 paid holidays.

+ Opportunity to work on Continuous Improvement Processes

**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 (https://careers.catalent.com/us/en) to explore career opportunities.

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 [email protected] . 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .