Manufacturing Engineer Engineer at YOH Services LLC in Grand Island, New York

Job Description:

Manufacturing Engineer needed for contract opportunity with Yoh's client in Grand Island, NY

The Big Picture - Top Skills You Should Possess:

• BS/BA Engineering Degree any discipline or related industry experience.


• A minimum of 7 years of equipment selection experience in a cGMP environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale manufacturing, and automation systems.


• Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is essential.

What You'll Be Doing:

• Lead Manufacturing Engineer on capital projects - overall project management, budget, schedule management, construction management, start-up, conceptual phases, project close-out, scope development, cost estimation, system design, equipment sizing and selection, procurement, installation, check-out, and validation (IQ/OQ & PQ).


• Lead system analysis to propose and implement improvements to achieve capacity expansion goals.


• Maintain interface with Project Leadership to status project details as frequently as required; prepare detailed plans for all project phases.


• Provide innovative technical solutions required to meet business objectives with emphasis on increased capacity.


• Provide support to capital planning process, new product development, and process automation.


• Perform validation of equipment, automation systems, data collection systems, and processes for the manufacturing operations.


• Preparing protocols, perform testing, collect samples, analyzing test results, and preparing summaries.


• Provide technical assessment and validation review/approval for engineering and process changes.


• Utilize Lean Manufacturing Tools such as SMED, 5S, Kaizen, Value Stream Mapping, and Kanban to achieve capacity gains.


• This position will independently provide direct technical engineering support for process and/or equipment upgrades, replacements, and modifications in manufacturing and manufacturing support environments.

What You Need to Bring to the Table:

• BS/BA Engineering Degree any discipline or related industry experience.


• A minimum of 7 years of equipment selection experience in a cGMP environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale manufacturing, and automation systems.


• Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is essential.


• Skilled at Lean approaches and tools (SMED, 5S, Kaizen, Value Stream Mapping, Kanban, more).


• Must be able to work independently as well as with teams, organize and manage projects by defining milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.


• Must have a thorough knowledge of manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.


• Candidates should have experience in pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.

Get Hired, Apply Now!

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.