Senior Process Engineer
Location: Kalamazoo, Michigan
About Our Client:
Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!
Key Responsibilities:
- Providing engineering support for product transfers, ensuring timely completion and documentation in accordance with standard procedures.
- Determining technical objectives of assignments and making informed decisions regarding project direction and outcomes.
- Monitoring and controlling project progress, ensuring sound application of engineering principles, and following applicable policies and procedures.
- Analyzing equipment to establish operating data, conducting experimental tests, and interpreting results to drive improvements.
- Leading or acting as an independent reviewer in process review meetings.
- Coaching and mentoring team members on process engineering topics and best practices.
- Ensuring process and product quality meets operational and material specifications.
- Selecting components and equipment based on analysis of specifications, reliability, and regulatory requirements.
- Collaborating with quality engineers to develop component-specific testing and inspection protocols.
- Participating in PFMEA, Control Plan, SOP, PPAP, and other internal qualification processes related to product transfers.
- Ensuring adherence to GMP and safety procedures in all engineering activities.
- Reviewing and approving validation documentation for equipment and process changes.
- Owning and supporting the development and execution of Validation Plans for complex projects.
- Writing, reviewing, and executing studies for process validation, including DOE, OQ, and PQ phases.
- Supporting and qualifying new equipment and systems used in NPI and product transfer initiatives.
Qualifications:
- Bachelor’s degree in an engineering discipline is required.
- Minimum of 4 years of experience in an FDA-regulated manufacturing or project environment.
- Proven experience with process and product validation.
- Proficiency in statistical methods, process mapping, and root cause analysis.
- Demonstrated experience coaching and mentoring others, coordinating complex projects and workstreams.
- Strong problem-solving skills related to technical manufacturing issues.
- Sound mechanical and structural design judgement and instincts.
- Hands-on experience with PLC setup, programming, and troubleshooting, including ladder logic.
- Experience in continuous improvement and project/process optimization.
- Green or Black Belt Six Sigma certification is a plus.
- Experience working with SCADA systems is preferred.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company
