Process Engineer II

About the role

Vantive, a vital organ therapy company focused on kidney care and dialysis, is hiring a Process Engineer II. The role covers process and product change projects, machine performance improvement, validation and label change projects, and supports manufacturing and maintenance engineering.

Key responsibilities

• Manage projects, product or process change and enhancement, liaising with stakeholders on requirements, specifications, deadlines, schedules, feasibility, implementation and validation.
• Assist in product design change projects affecting product performance and lead change control, specification change and validation activities.
• Improve manufacturing process predictability and reduce production costs by identifying productivity improvements, recommending machine part design changes and running feasibility studies.
• Use Lean tools to improve machine performance (e.g., OEE) and implement energy and water conservation projects.
• Keep processes stable, safe and capable of meeting product requirements, verify machine-made parts are safe and environmentally friendly, and run validation studies and process investigations.
• Analyze machine or process issues linked to customer complaints and implement corrective and preventive actions; may lead a group of technicians supporting manufacturing.
• Study parts life and set up preventive maintenance schedules for TPM activities.
• Handle label change requests from countries or regions with plant, quality and planning, including feasibility studies, draft artwork and drawings, and coordinate with supply chain, marketing and regulatory affairs.
• Ensure compliance with EHS procedures and requirements.

Required profile

• Degree in Mechanical or Mechatronic Engineering or equivalent.
• Minimum 3 years of experience in engineering project management and coordination.
• Good engineering background in industrial automation, electrical and controls engineering.
• Experience commissioning, debugging and validating new manufacturing machinery.
• Familiarity with basic GMP and other requirements for medical/pharmaceutical manufacturing.

Required skills

• Knowledge of IQ/OQ/PQ is an added advantage.
• Lean tools and TPM.