Project Engineer

About the Facility

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus features two manufacturing facilities approximately 5 miles from Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. It is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA-approved facility spans approximately 200,000 sq. ft. and 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 include 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.

About the Role

We have an opportunity for a Senior Project Engineer to join our team and manage engineering projects in an FDA-regulated environment. You will coordinate project scheduling, documentation, and communication across departments to ensure compliance and successful execution. This role involves working with internal teams and external vendors to meet project scopes and expectations, overseeing the site Project Governance Process and Capital Portfolio, and reporting to the Director, Facilities & Engineering.

Shift: Monday - Friday, 8am - 5pm
Location: Harmans, MD - BWI (100% onsite)

Responsibilities

• Assist in preparing regularly scheduled project reports.
• Manage invoices and purchase orders for capital projects and operational budgets.
• Follow up on execution and review of documents such as Deviations, Standard Operating Procedures, and Change Controls to ensure timely completion.
• Manage scheduling of multiple engineering projects across sites using project tracking software.
• Coordinate with schedulers and stakeholders to maintain timelines and reduce operational downtime.
• Act as the main point of contact with other department project managers or teams to drive deliverables.
• Help engineering subject matter experts create project scopes, goals, and deliverables aligned with business objectives.
• Manage overall project deliverables across departments and provide milestone updates.
• Prepare and maintain detailed project schedules, identifying major milestones for oversight and communication.
• Apply industry and engineering standards such as BPE, ISPE, GEP, and GAMP to ensure proper execution.
• Schedule and maintain vendors onsite and ensure appropriate documentation for engineering activities.
• Follow all Catalent safety and quality procedures and practices.
• Perform other duties as assigned.
• Support all sites in the Catalent MD network.

Requirements

• Bachelor’s degree in Engineering or related field. A combination of education, certification, and experience may be substituted as appropriate.
• Effective interpersonal and communication skills, both written and oral.
• 2+ years of experience managing engineering projects supporting process, laboratory, or facility equipment such as bioreactors, chromatography, tangential flow filtration, single-use mixers, gas testing systems, cell counters, compressed gases, clean utilities, and electrical delivery systems.
• Strong technical writing ability to clearly communicate technical ideas and concepts.
• Ability to work to targets and deadlines with strong planning, organizational, and prioritization skills.
• Customer-focused and team-oriented mindset.
• Proven problem-solving and continuous improvement skills.
• Ability to clearly communicate in English, both verbally and in writing.
• Able to navigate site mechanical spaces, including stairs, ladders, and low overhead areas as needed for project support.
• Able to lift up to 25 lbs.
• Shift and/or weekend work may be required to ensure project success.
• Ability to sit at a desk or computer for extended periods to prepare documentation, reports, and data analyses.
• Use of personal protective equipment including lab coats, gloves, safety goggles, and, when required, respiratory protection.

Preferred Qualifications

• Working knowledge of regulatory requirements for pharmaceutical operations.
• Ability to switch focus to support ongoing manufacturing operations in a dynamic environment.
• Six Sigma Green Belt or Black Belt certification.

Pay

The anticipated salary range for this position in MD is $90,000 – $110,000 plus bonus. The final salary offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs.

Benefits

• 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.