- Lead the execution of equipment qualifications, test method validations, and process validation changes.
- Develop and implement equipment and process modifications to meet quality standards and improve production efficiencies.
- Collaborate with process experts to create and document necessary validation efforts.
- Provide technical and sustaining engineering support in a manufacturing area.
- Review product development requirements for compatibility with processing methods.
- Interact with product design and development personnel to ensure process compatibility.
- Conduct statistical analysis and recommend documentation enhancements.
- Lead the innovation and optimization of new manufacturing concepts and processes for transfer to operations.
- Ensure compliance with regulatory processes and procedures.
- Education: Bachelor's Degree in Engineering or related field.
- Experience: Minimum of 4 years of relevant experience, with specific experience in TMV, IQ/OQ/PQ.
- Skills:
- Proven ability to lead projects and work independently.
- Strong critical thinking and clear communication skills.
- Experience with change order management, preferably in Agile systems.
- Advanced technical knowledge in equipment and process validation.
- Work Hours: Full-time, 40 hours per week.
- On-site Requirement: Yes
- Location Requirement: Must be local to the Minneapolis area, with work at both the R&D and manufacturing facilities as needed
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Sr. Process Engineer - Plymouth, United States - Primary Talent Partners
Description
Primary Talent Partners has a 2-Year Sr. Process Engineer contract opening with a Fortune 500 Medical Device client located in Plymouth, MN. Candidates must be local. Pay range is $57 to $64 per hour based on overall experience.Please note: You will be sitting on a W2 with Primary Talent Partners at an hourly basis without PTO/Benefits - We cannot provide sponsorships or accept C2C, OPT, or 1099 candidates
Position Overview:
We are seeking a seasoned Sr. Process Engineer with advanced knowledge and hands-on experience in equipment qualifications, test method validation (TMV), and process validation changes for new product development. This role requires a self-motivated engineer who excels in critical thinking, organization, and collaboration.
About the Role:
As the Sr. Process Engineer, you will play a crucial role in advancing our manufacturing capabilities and ensuring high standards of product quality and efficiency. You will be responsible for integrating equipment and material capabilities, developing manufacturing processes, and leading technical projects from design to implementation.
Key Responsibilities:
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