Senior Process Manufacturing Engineer

STERIS•Plymouth, MN

1d•Onsite

About The Position

Support and optimize chemical manufacturing processes to improve safety, quality, efficiency, reliability, and cost. Partner with Operations, Quality, Maintenance, Safety, R&D, and Supply Chain teams to troubleshoot issues, implement process and capacity improvements, support new product introductions, and ensure regulatory compliance. This is an onsite position and may require travel 5-10% of the time.

Requirements

Bachelor’s Degree in Engineering
Minimum of 5 years of process engineering experience in manufacturing, chemical processing, or related.
Experience managing engineering projects from the planning phase through validation.

Nice To Haves

BS in Chemical, Mechanical, or Industrial Engineering
Strong understanding of chemistry
Experience within the medical device manufacturing industry, or similar regulated industry.
Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
Experience in structured problem solving and use of statistical tools.
Training and experience in Lean and Six Sigma.

Responsibilities

Provide operations department with technical support to meet manufacturing quality and quantity objectives.
Provide general oversight and monitoring of process equipment – including project coordination for maintenance, upgrades, and repairs when needed.
Investigate process deviations, equipment issues, and production constraints.
Lead root cause analysis and implementation of corrective and preventive actions.
Create/edit written documents, test plans and reports that demonstrate technical rationale for associated decisions (e.g. qualifications, risk assessments, and work instructions).
Maintain Piping and instrumentation Diagrams “P&IDs” and drawings.
Lead initiatives to optimize safety, quality, delivery, and cost.
Apply Lean and Six Sigma methodologies.
Identify opportunities to reduce waste.
Support process improvement efforts.
Identify and propose capacity improvement opportunities.
Lead or support capital improvement projects.
Develop project scopes, budgets, schedules, and technical requirements.
Coordinate planning, procuring, installation, commissioning, validation and startup activities associated with new equipment.
Evaluate and provide input to product development teams to help ensure the successful introduction of a new product.
Create and document new chemical manufacturing processes as needed.
Train operations personnel on new processes.
Work with cross-functional teams to drive back lessons learned as new products/processes are being developed.