Project Engineer

Catalent•Harmans, MD

10d•$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, oversees the site Project Governance Process and Capital Portfolio, and reports to the Director, Facilities & Engineering. The position supports all sites in the Catalent Maryland network and is based 100% onsite at the Harmans, Maryland BWI campus, Monday through Friday, 8 a.m. to 5 p.m. Shift or weekend work may be required to ensure project success. The Harmans/BWI campus includes an approximately 200,000-square-foot FDA- and EMA-approved facility with 10 CGMP manufacturing suites, fill/finish, central services, testing laboratories, and a warehouse, as well as an approximately 145,000-square-foot facility under development that will house eight 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.

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, such as bioreactors, chromatography, tangential flow filtration, single-use mixers, gas testing systems, cell counters, compressed gases, clean utilities, and electrical delivery systems.
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 clearly.
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 navigate site mechanical spaces, including stairs, ladders, and low overhead areas, as needed for project support.
Ability to lift up to 25 pounds.
Ability to sit at a desk or computer for extended periods to prepare documentation, reports, and data analyses.
Ability 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 the execution and review of Deviations, Standard Operating Procedures, and Change Controls to ensure timely completion.
Manage schedules for multiple engineering projects across sites using project-tracking software.
Coordinate with schedulers and stakeholders to maintain timelines and reduce operational downtime.
Serve 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 project deliverables across departments and provide milestone updates.
Prepare and maintain detailed project schedules, identifying major milestones for oversight and communication.
Apply engineering and industry standards, including BPE, ISPE, GEP, and GAMP, to support proper execution.
Schedule and maintain onsite vendors and ensure appropriate documentation for engineering activities.
Follow Catalent safety and quality procedures and practices.
Support all sites in the Catalent Maryland network.
Perform other duties as assigned.