Documentation Specialist

• Manage manufacturing yield and process performance improvements.
• Lead and execute process validations (IQ, OQ, PQ).
• Design manufacturing processes, procedures, and production layouts.
• Optimize arrangement of machines and equipment for efficient plant operations.
• Specify sequences and procedures for fabrication, assembly, and tooling.
• Adapt machine/equipment design to suit production conditions.
• Integrate inspection and testing requirements into manufacturing plans.
• Inspect and assess machinery and equipment performance; initiate corrective actions as needed.
• Develop and implement statistical process control (SPC) methods.
• Provide guidance to engineering on design concepts and manufacturing specifications.
• Ensure compliance with regulatory and quality standards in all processes.

• Individual contributor in a professional discipline or specialty.
• Manages assigned projects from design to implementation.
• Collaborates with cross-functional teams to meet project goals.
• May mentor junior professionals or provide guidance to support staff.

• University degree (Level 8 or higher) in Mechanical, Polymer, Biomedical, or related Engineering/Science discipline.
• Minimum 5 years of experience in a highly regulated environment (e.g., MedTech, Pharma, or Plastics processing).
• Strong hands-on knowledge of:
• Extrusion, Blow Molding, Injection Molding.
• Adhesive and thermal bonding, RF welding, tip melting processes.

• Nylons,
• PVC,
• Polyethylene,
• Polypropylene,
• Pebax,
• PTFE,
• Polycarbonate.

• Statistical and analytical tools (SPC, SQC, DOE).
• DFA (Design for Automation), Lean Sigma, Minitab.
• Manufacturing documentation (MP, IP, BOM, CDP, IQ, OQ, PQ).
• CAD software: SolidWorks, AutoCAD.
• Proficient in Microsoft Office (Word, Excel, etc.).
• Manufacturing Automation
• Polymer Processing
• Increasing OEE metrics

• Effective verbal and written communication skills.
• Proactive, energetic, and self-motivated.
• Creative problem-solver with strong analytical thinking.
• Strong organizational skills; able to manage projects to schedule and budget.
• Team player with experience working cross-functionally.
• Results-oriented with a focus on continuous improvement and achieving plant KPIs.

PE Global