Industrial Process Specialist

1 week ago

Sydney, New South Wales, Australia beBeeManufacturing Full time $100,000 - $150,000

We are seeking a highly skilled and experienced Senior Manufacturing Support Engineer to join our team in Sydney. As a key member of our manufacturing support team, you will be responsible for maintaining efficient and productive engineering support to manufacturing and repair areas.

Key Responsibilities:
  • Provide first point of contact for manufacturing & repair on yield, quality, and throughput issues.
  • Solve identified manufacturing & repair problems.
  • Support NPI activities and ensure smooth transition into production.
  • Analyze and resolve complex manufacturing, quality, and compliance issues (e.g., CAPA, non-conformances, audit observations).
  • Ensure timely processing of NCRs, CAPAs, concessions, and change notes.
  • Identify process solutions and create plans to coordinate activities, mentor other engineers and technicians as needed.
  • Use proven methods to analyze failures and challenges, identify root causes, and implement solutions for yield and quality improvement.
  • Collaborate with other departments (warehouse, supply, procurement, NPI) to resolve manufacturing challenges.
Requirements:
  • At least 8 years of experience in a highly regulated GMP manufacturing environment preferred.
  • Minimum Bachelor's degree in Electrical Engineering, Technical, or Manufacturing qualification.
  • Experience working within a Quality Management System is highly desirable.
  • Experience with production management systems (e.g., Oracle).
  • Mandatory experience in Design of Experiments (DOE), developing protocols, and performing process validations (IQ/OQ/PQ).
  • Mandatory experience in designing process flows and production line layouts.
  • Exposure to a regulated environment working within a QMS framework; ISO exposure or good understanding of QMS is mandatory.
  • Knowledge of Change Management processes is highly desirable.
  • Strong project management skills, especially in process improvement and cost-saving projects, are an advantage.
  • Proven problem-solving, design, manufacturing/business process development, and personal influence skills.
  • Good interpersonal skills and written communication in English.
  • Candidates from Medical Device manufacturing industry have an added advantage.

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