Manufacturing Process Engineer
4 weeks ago
Position: Manufacturing Process Engineer Location: Carlsbad, CA, 92008 Duration: 12 Months Job Type: Contract Work Type: Onsite Shift: Monday- Friday 8.00AM-5.00PM How will you make an impact?
- The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects.
- This individual will have the ability drive resolutions to day-to-day quality issues and lead projects.
- The successful candidate will demonstrate strong organizational and communication skills as well as provide key examples of project management and process improvement experience.
- The Manufacturing Process Engineer is responsible for leading the day-to-day quality issues within manufacturing and supporting process improvements that may require capital investment.
- Optimize existing products and processes to improve efficiency and product quality within manufacturing and QC workstreams.
- Design, develop, and recommend engineering solutions to address capacity, cost, and quality issues.
- Define and document specifications by implementing industry standards and best practices to meet product, process and customer requirements and improve overall manufacturing performance.
- Drive Practical Process Improvements (PPI) with cross-functional teams by applying lean methodologies (including data analysis and statistical techniques/tools) to improve process efficiency.
- Prepare/present reports and data analysis to peers, supervisors, and other internal customers.
- Update manufacturing records (e.g. WINs, SOPs, and batch records) to address production issues, improve quality, and implement best practices.
- Coordinate validation activities of instruments and equipment used by the manufacturing and QC teams.
- Drive safety improvements to promote a safe working environment.
- Create and review project proposals and plans with partners and stakeholders.
- Manage project cost, documentation and timelines to ensure on-time completion of key deliverables.
- Effectively communicate barriers or issues and obtain needed support for a resolution.
- Work within our Quality Management System to effectively perform investigations and identify resolutions related to process failures and deviations.
- Participate in internal and external audits and respond to audit observations
- Identify and implement appropriate corrective and preventative actions.
- Collaborate with internal and external vendor for scheduling preventative maintenance and repairs of equipment
- Bachelor's degree in sciences and or Engineering (required) (preferred: Mechanical, Electrical, Biomedical, or Industrial Engineering degree)
- 2+ years of experience in manufacturing environment or similar
- 1+ years of experience in ISO or cGMP regulated manufacturing environment
- Experience with an ERP system and a basic understanding of cost accounting and standard manufacturing financials
- Experience with Process Improvement systems and tools (or similar Continuous Improvement and Lean Systems, i.e. Kaizen, Root Cause Counter Measure, etc.)
- Demonstrated experience working with cross-functional teams in projects of varying levels
- Experience with manufacturing processes and inter-departmental responsibilities
- Proficient in the use of Microsoft Office Software specifically Excel, Word, and PowerPoint
- Familiar with statistical methods (e.g. ANOVA, t-test, normality) and statistical tools/programs (e.g. JMP, Minitab)
- Strong collaborative skills and the ability to influence others without formal authority
- Excellent oral and written communication skills
- Is energized working in a fast-paced environment
- Consistent, diligent, and accurate in carrying out responsibilities
- Displays positive demeanor toward job and others
- Result oriented and data-driven
- Understands manufacturing operational flow which includes but not limited to Formulations, Filling and Assembly/Packaging
- Has strong project management skills
- Proactive approach that anticipates needs and problems while creating solutions
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