Director of Plant Manufacturing Engineering

Our US Medical Device client has an excellent opportunity to join them as a Director of Plant Manufacturing Engineering. The company is currently going through an expansion phase. As the Engineering Director you will be in charge from hiring and training new team members to managing tech projects and preparing the budget of the team within the manufacturing site.



Your main responsibilities will be:

• Oversight and Management: Ensure proper oversight of processes and systems impacting the engineering department. Plan and manage the engineering budget, CAPEX, and KPIs.
• Leadership and Development: Provide clear work direction, coaching, training, and development to the engineering team. Promote teamwork, drive innovation, and lead the team to achieve business goals.
• Regulatory Compliance: Ensure compliance with ISO13485, GMP/GDP, FDA, HSE, and AFCM regulatory requirements. Implement and adhere to the company's quality principles/FSP's at the site.
• Continuous Improvement: Initiate and lead key engineering/process improvement projects/initiatives. Contribute to the creation of prevention and recovery systems for potential threats. Monitor and improve equipment uptime to enhance overall performance and efficiency.
• Equipment Strategy and Compliance: Responsible for developing equipment re-capitalization strategy and line capacity expansion. Accountable for ensuring the site's compliance with the company's global ACM, BCM, and business compliance processes. Implement internal controls and adhere to relevant SOPs, policies, and guidelines.
• Validation Master Plan Activities and Product Stewardship: Accountable for ensuring departments execute and maintain the Validation Master Plan (VMP) activities, including annual revalidation process and cleaning procedures. Provide robust product stewardship for all products manufactured at the site and oversee product manufacturing processes throughout their commercial lifecycle.
• Technical Excellence and Innovation: Support excellence in manufacturing by setting technical standards, developing technical capabilities, and deploying new processes and technologies such as Quality by Design, Design of Experiment, and process Analytical Technologies. Collaborate with R&D and technical operations to implement new technologies and equipment.

Looking for candidates who have a vast in-depth experience within Manufacturing, Engineering and Plant Maintenance. Very knowledgeable with design engineering, process engineering and validation. At least 15 years of leadership experience. You would ideally come from a Pharmaceutical or Medical Device background such as Biotech, Biomedical, etc.



If you believe you fit the requirements for the role, please click APPLY NOW. Alternatively, you can email your CV to natassha.jham@ambition.com.sg. #LI-NME



Data provided is for recruitment purposes only. Business License Number: 10C5117. EA Registration Number: R1544135 - Regrettably, only shortlisted candidates will be notified.

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