-
Job Description
Job Summary: Manufacturing Specialist
Diagnose and implement permanent solutions to manufacturing issues, lead validation activities, and drive continuous improvement in a highly regulated environment.
Responsibilities:
- Solution Focused: Diagnose and implement permanent solutions to manufacturing issues using a structured problem-solving approach.
- Champion Problem Solving: Document and share knowledge to improve problem-solving skills.
- Drive Continuous Improvement: Lead the implementation of Lean/Six Sigma manufacturing principles to improve efficiency and quality.
- Regulatory Compliance: Ensure highest product quality through robust quality system processes such as GMP, NCR, and CAPA.
- Improve Production Flow: Achieve quality at source, rapid feedback from inspections, and ensure product specification requirements are met.
- Lead Validation Activities: Lead teams in the execution of validation activities to ensure compliance.
- Innovate Operational Performance: Analyze and implement improvements through key Overall Equipment Effectiveness (OEE) metrics: Yield, Uptime, and Performance.
- Mechanical Design: Design jigs and fixtures to meet manufacturing requirements, optimize machine changeover time, and improve maintenance.
- Environmental Impact Evaluation: Evaluate new equipment/processes/chemicals for environmental impact in conjunction with EHS.
- Adhere to Safety Requirements: Follow Plant Safety and Health & Safety requirements to ensure the well-being of yourself and others.
- Be Aware of Environmental Impacts: Understand the potential environmental impacts of your work and implications of non-conformance.
- Energy Performance: Contribute to enhanced energy performance by conserving energy (Lighting, Equipment, Air Conditioning etc).
- Continual Improvement Activities: Participate and provide feedback/suggestions for improvement in OH&S, Environmental, and Energy Management systems.
Qualifications:
- Knowledge/Experience: Validation techniques & applications (IQ/OQ/PQ, TMVs etc.), associated regulatory requirements, and statistical data analysis.
- Motivated & Flexible Approach: Demonstrate a motivated & flexible approach to work with results-oriented attitude.
- Excellent Interpersonal Skills: Excellent interpersonal, communication, planning, and organizational skills.
- Project Management: Ability to manage complex technical projects to strict deadlines using appropriate Project Management methods and tools (PMBOK methods).
- Team Leadership: Influential and motivated team member, promoting and leading cross-functional teamwork.
- Technical Guidance: Provides technical guidance & mentorship to technicians.
- Education: NQF Level 8 in a Technical Discipline (Mechanical, Manufacturing, Mechatronics, or Biomedical) with a minimum of two years relevant industry experience.
- Desirable Qualifications: Project Management and Six Sigma qualifications will be a distinct advantage.