Plant Engineer

Sharp Services; Macungie (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp is seeking a Plant Engineer for its pharmaceutical manufacturing facility in the Lehigh County area. The role focuses on maintaining equipment and processes, coordinating capital projects, and ensuring compliance with FDA and cGMP standards.

You will work with Central Engineering, Operations and Quality teams to sustain production and drive continuous improvement, include documenting procedures and supporting tech transfer and start-up activities.

Qualifications

• Experience maintaining pharmaceutical manufacturing equipment and systems.
• Ability to plan, coordinate and implement engineering projects from concept to start-up.
• Knowledge of FDA, cGMP and related regulatory guidelines.
• Strong problem-solving skills and cross-functional collaboration.
• Excellent documentation and communication abilities.

Responsibilities

• Oversee Equipment Maintenance: support Mechanical Electrical Services Group in monitoring and maintaining all manufacturing equipment and utilities.
• Troubleshooting and Problem Solving: diagnose equipment/process issues and coordinate effective solutions.
• Continuous Improvement: identify and implement process optimization and energy efficiency improvements.
• Capital Projects: plan and execute equipment installations, upgrades, modifications and write project docs (URS/FRS/FAT/SAT).
• Tooling Projects: work with vendors for tooling, drawings, layouts, and reverse engineering when needed.
• Training and Development: mentor technicians and operators on equipment operation, maintenance, and safety protocols.

Skills

Preventive maintenance

Troubleshooting

Continuous improvement

Project management

Regulatory compliance

Job description

Our dedication helps us make life better for patients. Living up to our reputation as can-do partners supports the business, and all the people within it. Our dedication makes us different and we’re looking for a Plant Engineer to join this amazing team.

The Plant Engineer has a crucial role in ensuring the smooth and efficient operation of our pharmaceutical manufacturing facility. This role 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. This role will support, manage, coordinate, and implement engineering projects at the designated Sharp facility from concept stages through completion. Ongoing support will continue through production start-up, technology transfer and ongoing support post qualification and start up. This function includes interdepartmental communications with Central Engineering, Operations, Finance, QC, Project Managers and Sales. Includes the functional authority for planning, organization, control, integration, and completion of engineering projects within area of assigned responsibility by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The following is a list of minimum responsibilities related to the Plant Engineer position. Other duties may also be assigned.
• Oversee Equipment Maintenance: Support Mechanical Electrical Services Group in monitoring and maintaining all manufacturing equipment, including but not limited 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: Utilize technical knowledge to 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 within the plant. 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 all relevant regulatory guidelines, including FDA, cGMP, and other applicable standards. Participate in audits and inspections, addressing any 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 the design, procurement, installation, and commissioning phases. Project Management includes developing and writing specific project documentation, such as URS, FRS, FAT, SAT as required. Bring all aspects of the project together including the formulation of design for product handling, the filling process and the machinery to accomplish the above. Coordinates with Project Team Manager and Mechanical & Electrical Services Group to assure technical project goals are aligned with overall project plan.
• Tooling Projects: Collaborate with existing 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 for parts and or assemblies. Maintain and update Engineering Turn Over Packages and databases such as Sample Order, Tool Set Number and Tooling Number.
• Shall possess a competent knowledge of all equipment and processes. Increase competence through individual technical data, interpretation of mechanical functions, comprehensive discussions with production mechanics, quality, equipment operators and manufacturers’ representatives. Work with Mechanical and Electrical Services Group to design tooling and machine parts based on layouts and package proposal drawings
• Training and Development: Stay updated with industry trends, new technologies, and best practices related to pharmaceutical manufacturing. Author and update equipment work instructions, preventative maintenance schedules. Train and mentor junior technicians and operators on equipment operations, maintenance, and safety protocols.