Manufacturing Engineer II

About the role

The Manufacturing Engineer II partners with the Production Department to drive process improvements, ensure high process capability, and support product transfers to manufacturing. The role involves validating changes, supervising technicians, and maintaining compliance with GMP standards.

Key responsibilities

• Identify and implement process improvement opportunities.
• Support troubleshooting, resolve defects, and minimize unplanned downtime.
• Develop and update SOPs, work instructions, and documentation.
• Lead root‑cause investigations and corrective‑action plans.
• Define and execute engineering reports, validation studies, and qualification phases.
• Design work‑center layouts, estimate production times, and perform capacity analysis.
• Apply Lean Manufacturing, Six Sigma, and OpEx principles to sustain continuous improvement.
• Evaluate automation and new technologies to enhance quality, safety, and cost efficiency.
• Train production supervisors, operators, and assemblers on new processes.

Required profile

• Experience in a manufacturing or production environment.
• Strong analytical skills for root‑cause analysis and process validation.
• Ability to supervise technicians and coordinate cross‑functional teams.
• Familiarity with GMP and regulatory documentation.

Required skills

• Lean Manufacturing
• Six Sigma
• Good Manufacturing Practices (GMP)
• Process validation and qualification
• Root‑cause analysis
• Automation and equipment installation
• Capacity analysis and work‑center layout design

What we offer

• Opportunity to lead continuous‑improvement projects.
• Collaborative environment with cross‑functional teams.
• Professional development in advanced manufacturing techniques.