Process Engineer 3

Merck•Jaffrey, NH

2d•Onsite

About The Position

The Process Engineer 3 is an advanced level engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing complex operating specifications and implementing and improving advanced 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 ensures process stability with a focus on maximizing safety, quality, yields, and productivity and requires close collaboration with cross functional team to assess risk, disposition product, and resolve problems.

Requirements

Bachelor’s Degree in Electrical Engineering, Mechanical Engineering, Chemical Engineering, Industrial Engineering or other technical field.
5+ 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 Engineering, Mechanical Engineering, Chemical Engineering or Industrial Engineering.
Electro-Mechanical, instrument and pneumatic knowledge along with 7+ years of experience applying this knowledge to process/equipment troubleshooting.
Proven ability to analyze complex 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 complex mechanical and electrical drawings and P&IDs.
Experience with Microsoft products, Minitab, and CAD software packages.
Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
Lean/Six Sigma certified (Green or Black Belt) with strong communication skills and experience working with HMI/PLC systems, including preferred coding knowledge.

Responsibilities

Expert at maintaining efficiency and upkeep of critical manufacturing equipment and able to lead effective troubleshooting activities.
Proficient at diagnosing and resolving complex process problems.
Proficient at developing complex project plans to drive process improvements or changes, and capable of leading a cross functional team to meet deadlines.
Able to anticipate challenges and roadblocks, and experiments with alternative and innovative solutions to avoid just refining existing solutions.
Proficiently evaluates/completes complex Process Engineering assessments and uses data (potentially in novel ways) to ensure appropriate disposition of product.
Provides guidance to less experienced team members and stakeholders.
Leads Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions, implementing robust solutions to address root cause and prevent events from reoccurring.
Generates, reviews and approves engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production operation.
Expert technical writing skills and strong understanding of Current Good Manufacturing Practices (cGMP).
Develops and improves manufacturing processes with strong statistical control while building alignment across cross-functional teams by translating strategy into clear goals and milestones, actively managing team dynamics, anticipating and preventing issues using experience and historical knowledge, and mentoring others through coaching and practical guidance to support overall team and business success.
Drives innovative solutions to reduce process variation and prevent failure modes and scrap risk.
Leads large-scale capital equipment and process initiatives, including fabrication, purchasing, validation (protocol/report writing, review, and execution), and change management, while ensuring compliance with industry standards and user requirements, managing timelines and capital requests, and proactively identifying and resolving roadblocks to meet operational and quality objectives.