Plant Engineer

Sharp Clinical Services; Macungie (Lehigh County); On-site; USD 75,000 - 110,000; Full time

Job summary

Sharp Clinical Services is seeking a Plant Engineer to ensure smooth operation of our pharmaceutical manufacturing facility. You will support maintenance, capital projects, and qualification activities from concept through startup, coordinating with Central Engineering, Operations, Finance, QC, and Project Managers.

The role requires 3–5 years of related experience, a engineering degree, and strong problem-solving, communication, and project-management skills to maintain compliance with FDA/cGMP

Qualifications

• Bachelor's degree in mechanical, chemical, or electrical engineering.
• 3–5 years of related engineering experience.
• Experience in troubleshooting manufacturing lines.
• Proven project management ability with multiple projects.

Responsibilities

• Oversee maintenance of manufacturing equipment and automated systems.
• Plan and manage capital projects, including equipment installations and upgrades.
• Coordinate with cross-functional teams for design, procurement, and commissioning.
• Ensure regulatory compliance (FDA/cGMP) and quality systems.

Skills

Troubleshooting

Project management

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

Engineering degree

Tools

AutoCAD

SolidWorks

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 regulatoryrequirements.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 drawingsTraining 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.EDUCATION and/or EXPERIENCE:Bachelor’s degree in mechanical, Chemical, or Electrical Engineering (or related field) with a minimum of 3 to 5 years related experience and/or training; or equivalent combination of education and experience. Also essential are direct experience in troubleshooting manufacturing lines; 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.Preferred attributes include working knowledge of applied manufacturing engineering principles; industry experience in food or pharmaceutical and experience working in FDA/cGMP compliance environments. Excellent understanding of regulatory requirements (FDA, cGMP, etc.) and quality systems. A working knowledge of AutoCad is a must and experience with Solidworks is a plus.