Oversee and execute multiple simultaneous capital projects in compliance with relevant engineering standards.
Evaluate, implement, and update engineering standards as needed.
Manage the design, procurement, and construction processes to align with company standards and project scope.
Ensure quality in both design and construction, with verifiable metrics.
Develop and update monthly project plans and expenditure reports, integrating financial oversight.
Prepare capital budget proposals and secure necessary approvals.
Build and maintain strong relationships with internal stakeholders and vendors to address issues, ensuring solutions are effectively identified and implemented.
Provide regular updates to stakeholders on project status, upcoming activities, and deliver progress reports to management.
Ensure a safe and compliant work environment through training, awareness, and adherence to safety guidelines and standard operating procedures (SOPs).
Maintain compliance with US and international regulatory agencies, including but not limited to FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP standards.
Qualifications:
Bachelor's degree in Mechanical, Electrical, or Chemical Engineering (other disciplines may be considered with relevant experience).
5+ years of experience in capital project execution.
Minimum of 3 years of experience in the pharmaceutical industry or other regulated environments.
Strong project management skills, including planning, tracking, and delivery.
Familiarity with cGMP and FDA regulations.
Excellent communication, interpersonal, and organizational skills.
Proficiency in Microsoft Office, MS Excel, and MS Project.
Strong leadership qualities, including managerial courage and the ability to drive change.
Adaptable to changing priorities and capable of managing multiple projects simultaneously.
Demonstrated experience leading teams, processes, or equipment-related initiatives.
Experience with Six Sigma and Lean Manufacturing principles.
Strong knowledge of process control, automation, and project management.