Senior Project Engineer

Overview

Senior Project Engineer for a GMP manufacturing facility for Gene Therapies. Supports engineering projects in an FDA-regulated environment, coordinating scheduling, documentation, and cross-department communication to ensure compliance and successful execution. Reports to the Director, Facilities & Engineering. Onsite location:
Harmans, MD – BWI.

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

• Bachelor’s degree in Engineering or related field (combination of education, certification, and experience may be substituted).
• 4 years of experience managing engineering projects supporting process, laboratory, or facility equipment (e.g., bioreactors, chromatography, tangential flow filtration, single-use mixers, gas testing systems, cell counters, compressed gases, clean utilities, electrical delivery systems).
• Effective interpersonal and written/oral communication skills.
• Strong planning, organizational, and prioritization skills with ability to meet targets and deadlines.
• Customer-focused and team-oriented mindset with problem-solving and continuous improvement abilities.
• Ability to communicate clearly in English (verbal and written).
• Ability to navigate site mechanical spaces (stairs, ladders, low overhead areas) and lift up to 25 lbs.
• Shift and/or weekend work may be required; ability to sit for extended periods to prepare documentation, reports, and data analyses.
• Use of personal protective equipment as required (lab coats, gloves, safety goggles, respiratory protection when needed).

• 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.

• Anticipated salary range: $94,000 – $128,000 Plus Bonus (MD).
• Benefits:
  Medical, dental, and vision effective day one; tuition reimbursement; paid time off and holidays; diverse, inclusive culture; career growth opportunities.