Expert Technical Solutions is seeking a Project / Process Engineer for one of our premier clients, industry leading clients in Norcross, GA.
This is a Direct Hire position offering excellent compensation and benefits!
You will be a key problem solver and a potential core team leader to plan and lead cross-functional team/processes that support manufacturing by implementing equipment and process modifications to improve production efficiencies.
Our ideal candidate will have experience in developing and conducting statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) to improve yield and product quality, and lead projects to include safety, facility renovation and expansion projects from concept through design and construction supporting operations.
- Facilitate the development of user requirement specifications for equipment sourcing, engage with OEM suppliers and provide technical guidance and oversight and lead capital projects to meet the needs of the end users
- Responsible for assisting in root cause analysis, developing proposed solutions, assessing design feasibility and driving resolution for a broad array of operational problems
- Design experiments using DOE methodology, analyze the test results using statistical tools and interpret the results to provide feedback for design improvements
- Responsible for managing projects associated with new equipment purchases, safety, facility, renovations and expansions
- Experience with project management methodologies to endure successful project execution and implementation
- Draft, modify and maintain complete facility diagram library using AutoCAD
- Responsible for leading projects from preparing RFI's through SAT/Commissioning in preparation for Qualification
- Interpreting the results correctly and providing feedback effectively for design improvement
- Bachelor's Degree required
- Strong mechanical skills as well as knowledge of Mechanical/Electrical/Plumbing drawings
- Familiarity with clean room operations, designs, sterile filtration processes and biological processes.
- 4+ years relevant experience as an engineer in an operations support environment
- Six Sigma Certification, preferred
- Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
- Strong analytical and problem solving skills and a background in continuous improvement activities
- Instrument automation or scientific instrumentation, preferred
- Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes
- Strong project management, prioritizing and multi-tasking skills to work within tight deadlines
- Experience with requirements development from user needs
- Experience with design transfer functions
- Risk management expertise
- Track record of career advancement
- Experience with Equipment Qualification IQ/OQ/PQ
- Experience with biological processes