Manufacturing Process Engineer
4 weeks ago
StarrTrax is seeking a highly skilled Manufacturing Engineer II (Sterile) to lead and implement major projects involving technical systems. The ideal candidate will have a strong background in manufacturing, process development, and validation, with excellent communication and leadership skills.
Key Responsibilities:- Lead process mapping and continuous improvement activities of production lines
- Provide statistical analysis of processes and implement data-driven solutions
- Collaborate with cross-functional teams to achieve objectives and drive business results
- Develop and implement control strategies and systems for automated manufacturing equipment
- Conduct root cause analysis of customer complaints and implement corrective actions
- Establish and maintain operating procedures and maintenance requirements
- Lead experimental and validation protocols for equipment, processes, and materials
- Support product portfolio activities, including feasibility studies and product introductions
- Propose and implement cost-reduction initiatives and facility layout improvements
- Mentor and train junior engineers in troubleshooting and best practices
- Apply project management tools to coordinate and implement CAPEX and equipment-related projects
- Ensure compliance with cGMP and ISO standards, as well as safety guidelines and policies
- Bachelor's degree in Mechanical, Electrical, Pharmaceutical, or Materials Engineering (required)
- MS degree and/or Six Sigma certifications (preferred)
- 4+ years of relevant manufacturing experience in a sterile environment
- Proficiency in statistical software (Minitab, JMP) and design software (SolidWorks, CAD, AutoCAD)
- Proven knowledge of cGMP and ISO standards (9001, 15378)
- Excellent communication and leadership skills, with the ability to read and speak English
StarrTrax offers a dynamic and fast-paced work environment, with opportunities for professional growth and development. We are committed to providing a safe and inclusive workplace, and we offer competitive compensation and benefits packages.
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