Project Engineer

Catalent Pharma Solutions•Glen Burnie, MD

27d•$90,000 - $110,000•Onsite

About The Position

Catalent is seeking a Senior Project Engineer to manage engineering projects in an FDA-regulated environment. The role coordinates project scheduling, documentation, and communication across departments to support compliant and successful execution. It works with internal teams and external vendors to ensure project scopes and expectations are met, and oversees the site Project Governance Process and Capital Portfolio. The position reports to the Director, Facilities & Engineering and supports all sites in Catalent’s Maryland network. The role is based 100% onsite at the Harmans, Maryland BWI campus, Monday through Friday, 8:00 a.m. to 5:00 p.m. The campus has FDA-licensed CGMP gene therapy manufacturing facilities supporting Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. The position manages project reports, invoices, purchase orders, schedules, deliverables, milestones, and vendor activities. It also coordinates document review and execution, supports project scope development, applies applicable industry and engineering standards, and follows Catalent safety and quality procedures. Shift and/or weekend work may be required to ensure project success.

Requirements

Bachelor’s degree in Engineering or a related field; a combination of education, certification, and experience may be substituted as appropriate.
At least 2 years of experience managing engineering projects supporting process, laboratory, or facility equipment.
Effective written and oral interpersonal and communication skills, including the ability to communicate clearly in English.
Strong technical writing ability to 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.
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.
Able to sit at a desk or computer for extended periods to prepare documentation, reports, and data analyses.
Able to use personal protective equipment, including lab coats, gloves, safety goggles, and respiratory protection when required.
Shift and/or weekend work may be required to ensure project success.

Nice To Haves

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.

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 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.
Support all sites in the Catalent Maryland network.
Perform other duties as assigned.