Associate Production Support Engineer

Position Summary.

The Associate Production Support Engineer will manage and maintain all equipment, fixtures and tools used in the manufacturing production process. This position is responsible for the care, maintenance, and repairs of equipment and systems in a cGMP manufacturing environment. Coordinates and performs ongoing preventive and corrective maintenance on various process equipment, fixtures and tooling within manufacturing.

Essential Duties and Responsibilities. 

• Perform preventative maintenance required for all equipment as defined in SOPs in order to keep equipment operating at a high level of quality and reliability.

• Develop, update and maintain SOPs for equipment, fixtures, and tooling used in production and servicing of production equipment.

• Establish, maintain and document regular maintenance schedules for all equipment, tools and fixtures

• Provide support and/or training for production operators on equipment operation.
•        Establish contact, coordinate, and liaise with vendors as needed for onsite service, repairs, and warranty claims when applicable; supervise and inspect vendor work to assure quality
• Develop and manage equipment calibration schedules, and coordinate the calibration of fixtures, tools and equipment, while minimizing impact to production schedules

• Assist engineering and manufacturing management in monitoring and improving production equipment efficiency, uptime, and failures.

• Inventory parts and tools used in the upkeep and maintenance of equipment, tools, and fixtures

• Follow company Standard Operating Procedures (SOPs) and directives

• Help improve processes and provide feedback to ensure better output

• Keep a clean and well-maintained workspace and equipment

• Additional responsibilities as assigned

Education, Qualifications, and/or Experience. 

• Associate’s degree or higher, in an engineering or science discipline required

• Minimum 5 years manufacturing experience, including at least two (2) years of experience in maintaining and servicing high tech production equipment required

• Prior experience working in an FDA regulated or ISO manufacturing environment with GMP knowledge preferred

• Ability to follow strict protocols and adhere to quality standards required

• Ability to read and understand manufacturing instructions and SOPs, schematics, and engineering drawings required

• Basic computer skills, including MS Office, internet and email

• Flexibility to handle changing needs and demands, as well as navigate process improvements

• Must possess strong teamwork skills and work well with others

• Must have strong communication skills, with the ability to direct and lead coworkers

Physical Requirements.  

• Repetitive Motion: Mostly computer use

• Weight Lifting: < 25 lbs

• Ability to sit or stand for extended periods of time

• Must possess good communications skills

• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas