Senior Project Engineer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

Catalent Pharma Solutions in Harmans, MD is hiring a Senior Project Engineer who will manage engineering projects, including both capital and smaller-scale initiatives in an FDA regulated environment. They will coordinate project scheduling, documentation, and interdepartmental communication/coordination to ensure compliance and successful execution. This position will work with internal departments, engineering, and external vendors to make sure project scopes and expectations are clearly understood and executed. Senior Project Engineer will have responsibility for management of the site Project Governance Process and Capital Portfolio.

This is a full-time, salaried role. This is on site. The core hours are Monday – Friday 9:00AM – 5:00PM

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Assist in the preparation of regularly scheduled project reports;

• Manage invoices and POs for Capital projects and to support operational budget’

• Follow up on execution/review of documents, such as Deviations, SOPs, Change Controls, etc., to ensure they are completed in a timely manner, as it relates to project goals;

• Manage the scheduling of multiple engineering projects across multiple sites, and ensure timelines and scopes are feasible through the use of Project Tracking Software;

• Coordinate with schedulers and stake holders to maintain project timelines to effectively to reduce operational downtime.

• Act as the main point of contact with other department project managers or project teams to drive project deliverables.

• Help engineering SME create project scopes, goals, and deliverables that support business goals in collaboration with stakeholders.

• Manages the overall project deliverables across internal departments and provide milestone updates.

• Prepare and maintain detailed project schedules, including identification of major milestones for overseeing, controlling, communicating, and managing all activities required to complete projects.

• Utilize Industry and Engineering standards such as BPE, ISPE, GEP, and GAMP to ensure projects are executed properly.

• All other duties as assigned;

The Candidate

• Bachelor’s degree in Engineering, or related field required. PMP Certified preferred;

• Effective interpersonal and communication skills (written and oral) are required;

• 4+ years’ experience required managing engineering projects in a role 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;

• Working knowledge of the regulatory requirements for pharmaceutical operations;

• Able to navigate site mechanical spaces, including stairs, ladders, low overhead areas as needed for project support;

• Shift and/or weekend work may be required to ensure project success;

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 Hours + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Company match on donations to organizations

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement – Let us help you finish your degree or start a new degree!

• WellHub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! 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 is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. 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.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .