Manufacturing Process Engineer

4 weeks ago


Philadelphia, Pennsylvania, United States StarrTrax Full time
Job Title: Manufacturing Engineer II (Sterile)Job Summary:

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
Requirements:
  • 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
What We Offer:

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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