The successful candidate is responsible for designing, implementing, and optimizing manufacturing processes to improve efficiency and reduce costs. They will collaborate closely with cross-functional teams, train and support staff on new processes and equipment, and ensure compliance with safety policies and procedures.

KEY RESPONSIBILITIES

• Assist in the planning, execution, and monitoring of capital and infrastructure projects, ensuring alignment with project goals, timelines, and budgets.

• Lead process and equipment validation ensuring regulatory compliance and consistent high-quality products.

• Monitor production data and Key Performance Indicators (KPIs) to highlight trends and opportunities for improvements.

• Ensure that all manufacturing processes and equipment meet the required standards and specifications through rigorous testing and validation.

• Follow IQ, OQ, PQ methodologies when applicable.

• Develop and manage qualification documentation for new equipment, processes, and systems, ensuring accuracy and completeness.

• Track the status of qualification activities and provide regular updates to stakeholders on progress and issues.

• Conduct assessments of packaging materials and processes to ensure they meet quality, safety, and compliance standards.

• Provide recommendations for packaging improvements and partner with suppliers and internal teams to implement changes.

• Identify and implement strategies and methodologies (Lean, Six Sigma) for continuous improvements, efficiency gains, and waste reduction including tracing performance of implemented changes.

QUALIFICATIONS

• Bachelor's degree in mechanical or electrical engineering

• 5+ years engineering experience working in a manufacturing company; pharmaceutical experience preferred.

• Certification in Lean Six Sigma or other process improvement methodologies would be considered an asset.

• Strong critical thinking and problem-solving skills to identify and implement improvements in production processes

• Ability to manage multiple projects and prioritize tasks effectively

• Keen attention to detail with strong documentation and organizational skills

• Excellent communication and presentation skills

• Competent with MS Office and AutoCAD

• Familiarity with GMP (Good Manufacturing Practices) and other relevant regulatory standards in the pharmaceutical industry.

• Proven experience in managing projects from conception through completion, including budgeting and timeline management.

• Experience with manufacturing software and systems, such as ERP (Enterprise Resource Planning) systems.