Plant Engineer

About the role

We’re looking for a Plant Engineer to join our team and play a crucial role in ensuring the smooth and efficient operation of our pharmaceutical manufacturing facility. This position requires innovative thinking and will contribute to maintaining and optimizing the plant's equipment, systems, and processes to ensure compliance with industry standards and regulations. The Plant Engineer will support, manage, coordinate, and implement engineering projects from concept through completion, including ongoing support through production start-up, technology transfer, and post-qualification phases. This role involves interdepartmental collaboration with Central Engineering, Operations, Finance, QC, Project Managers, and Sales.

Responsibilities

• Oversee Equipment Maintenance: Support the Mechanical Electrical Services Group in monitoring and maintaining all manufacturing equipment, including production machinery, utilities, and automated systems. Develop and implement preventive maintenance programs to minimize downtime, optimize performance, and ensure safe operation.
• Troubleshooting and Problem Solving: Identify, diagnose, and resolve equipment or process-related issues promptly. Collaborate with cross-functional teams to establish effective solutions, ensuring minimal disruption to production activities.
• Continuous Improvement: Identify opportunities for process optimization, cost reduction, and energy efficiency improvements. Propose and implement innovative ideas to enhance productivity, quality, and safety while adhering to regulatory requirements.
• Compliance and Documentation: Maintain accurate records of equipment maintenance, repairs, and incidents. Ensure compliance with FDA, cGMP, and other applicable regulatory guidelines. Participate in audits and inspections, addressing findings promptly.
• Capital Projects: Collaborate with Central Engineering and Electrical Controls and Serialization teams to plan and execute capital projects, including equipment installations, upgrades, and modifications. Provide technical expertise during design, procurement, installation, and commissioning phases. Develop project documentation such as URS, FRS, FAT, and SAT as required.
• Tooling Projects: Collaborate with equipment vendors to obtain tooling and service quotes. Responsible for project proposal drawings, review of artwork drawings, material layouts, and web layouts. Capable of reverse engineering parts or assemblies. Maintain and update Engineering Turnover Packages and databases such as Sample Order, Tool Set Number, and Tooling Number.
• Training and Development: Stay updated with industry trends, new technologies, and best practices in pharmaceutical manufacturing. Author and update equipment work instructions and preventive maintenance schedules. Train and mentor junior technicians and operators on equipment operations, maintenance, and safety protocols.

Requirements

• Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering (or related field) with a minimum of 3 to 5 years of related experience and/or training; or equivalent combination of education and experience.
• Direct experience in troubleshooting manufacturing lines and ability to plan and coordinate projects.
• Strong written, verbal communication, and presentation skills.
• Proven experience in project management and ability to handle multiple projects simultaneously.
• Working knowledge of applied manufacturing engineering principles; industry experience in food or pharmaceutical manufacturing preferred.
• Experience working in FDA/cGMP compliance environments.
• Excellent understanding of regulatory requirements (FDA, cGMP, etc.) and quality systems.
• A working knowledge of AutoCAD is required; experience with SolidWorks is a plus.