Catalent, Inc

Senior Project Engineer

Harmans, MD · Senior

Sponsorship not specified$94k-$128kDetected 6 days ago

Process ImprovementClinical TrialsGMPFDA RegulatoryCommunicationProblem SolvingWriting

About the role

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 ensure project scopes and expectations are met.
You will also oversee the site Project Governance Process and Capital Portfolio, reporting to the Director, Facilities & Engineering.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
We have an opportunity for a Senior Project Engineer to join our team and manage engineering projects in an FDA-regulated environment.
Manage invoices and purchase orders for capital projects and operational budgets.
Manage scheduling of multiple engineering projects across sites using project tracking software.
Follow up on execution and review of documents such as Deviations, Standard Operating Procedures, and Change Controls to ensure timely completion.
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.

Bachelor's degree in Engineering or related field.
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.
Proven problem-solving and continuous improvement skills.
Ability to clearly communicate in English, both verbally and in writing.
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.
Working knowledge of regulatory requirements for pharmaceutical operations.

The anticipated salary range for this position in MD is $94,000 - $128,000 Plus Bonus.
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.
Defined career path and annual performance review and feedback process.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

This listing is sourced directly from Catalent, Inc's careers page and normalized into a canonical job model.