Process Engineer

Merck•Jaffrey, NH

9d•Onsite

About The Position

The Process Engineer 1 is an entry level engineering position responsible for supporting the manufacture and testing of membranes used in high purity filters, prioritizing safety, and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing operating specifications and implementing and improving basic manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality. This position works with higher level engineers to ensure process stability with a focus on maximizing safety, quality, yields, and productivity and requires collaboration with cross functional team to assess risk, disposition product, and resolve problems.

Requirements

Bachelor’s degree in chemical engineering, electrical engineering, mechanical engineering, business management, computer science or other life science discipline.
OR High School diploma and 8+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Nice To Haves

Master of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.
Basic Electro-Mechanical, instrument and pneumatic knowledge along with 2+ years of experience applying this knowledge to process/equipment design and/or troubleshooting.
Proven ability to analyze data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
Read and understand basic mechanical and electrical drawings and P&ID’s.
Experience with Microsoft products, Minitab, and CAD software packages.
Demonstrates a strong foundation in safe work practices (including lockout/tagout and electrical safety), Lean/Six Sigma experience (Green or Black Belt), excellent communication skills, hands-on expertise with automated fluid skids, web processes, and process development, as well as experience in Process Safety Management and Class I Division 1 environments.

Responsibilities

Maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
Exchanging ideas with other team members and participating/leading technical discussions to realize process improvements and changes.
Providing basic process support on assigned Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA), implementing robust solutions to address root cause of issues.
Generating, reviewing, and approving engineering, manufacturing, and quality procedures necessary to support production operation, equipment validation/revalidation, and product launch.
Ensuring adherence to Current Good Manufacturing Practices (cGMP).
Leading and implementing basic level changes to reduce process waste and variation, and improve yields.
Generating capital requests to support new processes and capital equipment purchase.
Generating capital requests for new processes and equipment, leading and participating in equipment and process validation activities (including protocol/report development, review, and execution), and managing change requests by initiating, reviewing, and approving, implementing solutions to support operational needs.
Working collaboratively with cross-functional teams, taking ownership of project tasks and deadlines, and conducting basic process engineering assessments using data to make informed product disposition decisions.
Reviewing capital equipment fabrication activities to ensure manufacturing, installation, and operational testing conform to industry standards, and user requirements.