Process Optimization Engineer (GMP/ISO)

Align Technology, Inc.; Wrocław; On-site; PLN 100,000 - 145,000; Full time

Benefits offered by this job

Private healthcare Luxmed

Multisport card

Private insurance

Meal vouchers

Co-financing of company products

Employee Support Program

Job summary

Align Technology, Inc. in Wrocław is seeking a Process Engineer to improve production processes for efficiency, quality, costs, safety and ergonomics, while ensuring compliance with GMP/ISO/FDA standards.

You will implement production processes, optimize machines, perform data-driven quality analysis, and collaborate with Maintenance. You will also lead PFMEA updates, line balancing, and cost-reduction initiatives, with emphasis on project-driven process improvements.

Qualifications

• Bachelor degree in Automatics & Robotics, Mechanical or Chemical Engineering.
• At least 2 years of experience in a similar role (Medical or Automotive).

Responsibilities

• Implement and optimize production processes and machines.
• Initiate and implement process improvements.
• Solve quality and machine problems using data analysis.
• Collaborate with Maintenance on technical issues.
• Balance production lines.
• Update PFMEA, supervise process documentation.
• Lead cost-reduction activities.
• Plan and conduct validations per GMP/ISO/FDA.
• Prepare validation plans and reports.
• Perform statistical analysis of process capability.
• Report deviations and update KPI statuses.
• Assess ergonomics of equipment and workplaces.

Skills

Process optimization

Data analysis

Quality control

Cross-functional collaboration

Education

Bachelor's degree in Automatics & Robotics or Mechanical/Chemical Engineering

Job description

Align Technology, Inc. in Wrocław is seeking a Process Engineer to improve production processes for efficiency, quality, costs, safety and ergonomics, while ensuring compliance with GMP/ISO/FDA standards.

You will implement production processes, optimize machines, perform data-driven quality analysis, and collaborate with Maintenance. You will also lead PFMEA updates, line balancing, and cost-reduction initiatives, with emphasis on project-driven process improvements.