Senior Project Engineer

About the role

We are seeking a Senior Project Engineer to join our team and manage engineering projects in an FDA-regulated environment. The role involves coordinating project scheduling, documentation, and communication across departments to ensure compliance and successful execution. This role also involves working with internal teams and external vendors to ensure project scopes and expectations are met.

Responsibilities

• Aid 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.
• 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.

Requirements

• Bachelor’s degree in Engineering or related field.
• Minimum of 4 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.
• Effective interpersonal and communication skills, both written and oral.
• 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 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.
• Able 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.

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 preferred.

Skills

• 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 preferred.

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.

Pay

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.

Company Information

Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Personal initiative. Dynamic pace. Meaningful work.

Contact Information

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Important Security Notice

California Job Seekers can find our California Job Applicant Notice HERE.