Sr. Project Engineer
Rochester, NY Posted: 5/26/2021
Works as a key technical resource in supporting company objectives with respect to engineering design and project management in the implementation of capital projects and non-capital process improvements.
- Working with and/or leading the team to help identify, develop and execute projects to meet or exceed all company goals with respect to quality, schedule and spending.
- Developing design concepts with the users.
- Providing detailed design documents for some projects (e.g. P&IDs, construction drawings); equipment and instrument specification and installation; engineering calculations, developing request for proposals to bid projects; coordination with customers, contractors and consultants; reviewing documents, preparing capital appropriation requests, creating purchase orders, reviewing and paying invoices; monitoring progress; assisting with training; executing commissioning activities; and ensuring proper project closure.
- Projects include but are not limited to: manufacturing systems, packaging systems, process piping, utility systems, facilities new construction and upgrades, and all other categories of capital spending.
- Provides technical leadership of equipment, automation and / or facility improvement projects within an operating commercial manufacturing facility with a primarily focus on technical deliverables around feasibility/ conceptual development, basic design, detailed design, implementation, commissioning and qualification.
- Additionally, this position will have responsibility for overall project management of new and ongoing projects across functions.
- These responsibilities include, but are not limited to, planning, leading, resourcing all aspects of cross-functional projects from development through commercialization. Project activities are supported through matrixed resources, and the position ensures close and open communication within the site and with customer representatives.
- Leads external engineering and design teams, as well as internal resources, to develop capital project proposals to address complex manufacturing issues.
- Determines project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.
- Provides Technical support for small molecule OTC and branded products.
- BS/MS degree in an engineering discipline.
- A minimum of 15 years in either a manufacturing environment, or equipment and packaging technology.
- A minimum of 5 years regulated industry experience required, pharma experience preferred.
- Hands on experience with small molecule solids and liquids manufacturing equipment including compression and capsule filling, fluid bed dryers, and/or liquids batch processing desired.
- Experience in sterile manufacturing a benefit but not required.
- Strong background in technical troubleshooting, problem solving.
- Detailed knowledge of equipment operation and validation requirements.
- Proficient knowledge of pharmaceutical cGMP requirements and systems.
- Ability to specify, procure, oversee installation, and commission systems and processing equipment.
- Strong project management skills.
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
- Intermediate Excel skills.
- Intermediate Microsoft Project skills.
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