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Job Details


Engineering


Sr. Project Engineer  Rochester, NY  Posted: 5/26/2021
Job Description

Job ID#:

2714

Job Category:

Engineering

Position Type:

Employee

Duration:

Direct Hire


JOB SUMMARY: 
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. 
 
RESPONSIBILITIES:
  • 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.
 
QUALIFICATIONS/EXPERIENCE: 
  • 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.

 
Job Requirements



 

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