Your RoleThe Process Engineer I is an entry 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 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. Shift hours 8AM - 4:30PM.
Duties Include:
- Responsible for maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
- Exchanges ideas with other team members and participates leads technical discussions in to realize process improvements and changes.
- Provides basic Leads process support on assigned Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA), implementing robust solutions to address root cause of issues.
- Works collaboratively with cross-functional teams to lead project tasks, take ownership of deadlines, and perform basic process engineering assessments using data to appropriately disposition product.
- Responsible for generating, reviews, and approve engineering, manufacturing, and quality procedures necessary to support production operation, equipment validation/revalidation, and product launch.
- Leads capital and change initiatives by generating capital requests, overseeing equipment fabrication and validation, and ensuring new processes and equipment meet industry standards, user requirements, and operational needs.
- Ensures adherence to Current Good Manufacturing Practices (cGMP).
- Leads and implements basic level changes to reduce minimize process waste and variation, and improve yields leads yield improvement and product performance initiatives.
Who You AreMinimum Qualifications- Bachelor's Degree in a STEM-related field, such as Mechanical Engineering, Electrical Engineering, Chemical Engineering, Industrial Engineering, Biology, Chemistry, Biotechnology, Computer Science, or a related technical discipline. Degrees in Technical Management, Business Management, Operations Management.
OR
- High School Degree 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.
Preferred Qualifications- Master's 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.
- Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
- Lean/Six Sigma experience, with green or black belt.
- Strong communication skills.
Pay Range for this position: $72,600-$110,700 annually
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
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