The Engineering Manager will oversee all engineering operations in a cGMP-compliant diagnostic kit manufacturing facility. This individual will lead a team of engineers to ensure that production processes, equipment, and systems meet cGMP standards and support the reliable, efficient, and safe manufacturing of high-quality diagnostic kits. The Engineering Manager will work closely with the administration, Quality, Production, and maintenance teams to drive continuous improvement, enhance process robustness, and ensure that all regulatory and safety standards are met.

Key Responsibilities:
1. Leadership and Team Management
2. Lead and mentor a team of engineers to support operational goals and maintain cGMP compliance.
3. Foster a collaborative work environment that emphasizes teamwork, accountability, and technical excellence.

Evaluate team performance, provide constructive feedback, and develop training programs to upskill staff.
5. Process Improvement and Optimization
6. Analyze current production processes to identify bottlenecks, inefficiencies, and areas for improvement.
7. Lead efforts to implement lean manufacturing principles and continuous improvement methodologies.

Ensure that equipment and processes are optimized to increase throughput, reduce costs, and maintain high product quality.
9. Equipment and Facility Management
10. Oversee the installation, maintenance, and calibration of equipment in compliance with cGMP standards and regulatory requirements.
11. Develop and manage a preventive maintenance schedule to maximize equipment uptime and minimize unexpected downtime.

Lead troubleshooting efforts and coordinate corrective actions for equipment and facility-related issues.
13. Project Management
14. Manage capital projects related to equipment upgrades, process improvements, and facility expansions from concept to completion.
15. Develop project scopes, budgets, and timelines, and ensure all projects are completed on time, within budget, and in compliance with regulatory standards.
16. Collaborate with cross-functional teams to ensure project alignment with overall operational objectives.
17. Compliance and Documentation
18. Ensure compliance with all relevant regulations, including cGMP, NDA, and ISO standards, through rigorous documentation and record-keeping.
19. Work closely with the quality assurance team to conduct audits, investigations, and root cause analyses for any deviations or non-conformances.
20. Implement effective change control processes to manage modifications to processes, equipment, or facility layout.
21. Environmental Health and Safety (EHS) Standards
22. Develop and enforce Environmental Health and Safety procedures to ensure a safe working environment for all employees.
23. Conduct risk assessments and implement mitigation measures to reduce potential hazards.
24. Ensure compliance with EHS regulations and lead initiatives to continuously improve safety performance.
25. Vendor and Stakeholder Management
26. Manage relationships with equipment suppliers, service providers, and contractors to ensure high-quality service and support.
27. Collaborate with internal stakeholders, including quality, regulatory, supply chain, and production teams, to ensure seamless operations.
28. Support quality audits and inspections by regulatory authorities, addressing any engineering-related questions or findings.

Qualifications:
• Minimum Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field) Master’s degree is an added advantage.
• Minimum of 5 years of engineering experience in a cGMP-regulated environment, with at least 3-5 years in a managerial or supervisory role in pharmaceutical, biotechnology, or diagnostic kit manufacturing.
• Project Management Professional (PMP) and cGMP training are desirable.
• Technical Knowledge: Strong understanding of cGMP requirements, NDA regulations, and ISO standards in a manufacturing environment.
• Leadership and Communication: Proven leadership skills with the ability to effectively communicate and collaborate across departments and with external stakeholders.
• Problem-Solving: Proficiency in troubleshooting complex issues and implementing effective corrective actions.
• Analytical Skills: Data-driven mindset with experience in using statistical and analytical tools to monitor process performance and drive improvements.
• Project Management: Strong organizational and project management skills with a track record of managing complex engineering projects from start to finish.
• HSE Awareness: In-depth knowledge of health, safety, and environmental regulations and best practices in a manufacturing setting.