Project Manager - Engineering
Catalent Pharma Solutions - Harmans, MD
posted 16 days ago
About the position
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 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 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. The Engineer will have responsibility for management of the site Project Governance Process and Capital Portfolio.
Responsibilities
- 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 stakeholders to maintain project timelines to effectively 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
- Manage 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
- Schedule and maintain vendors onsite and appropriate documentation for engineering activities
- All other duties as assigned
Requirements
- Bachelor's degree in Engineering, or related field required
- Effective interpersonal and communication skills (written and oral) are required
- Two (2)+ years' experience 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
- A working knowledge of the regulatory requirements for pharmaceutical operations
- A combination of education, certification, and experience may be substituted for the above, as appropriate
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Benefits
- 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
