Job description

JOB SUMMARY:
The Process Equipment Setup Mechanic responsible for adjusting, changing over, troubleshooting, of Process equipment and systems. Performs documentation as required to record maintenance and repair activities, and to support Document Control, Change Control, and Validation activities.

DUTIES AND RESPONSIBILITIES:
1. Perform changeovers, adjustments, basic troubleshooting and support for the process equipment.
2. Disassemble, clean and store away equipment changes parts.
3. Monitors performance of equipment, machines, tools and provides input regarding potential problems.
4. Team member for problem solving to resolve production and quality issues. Assists with investigations. Works collaboratively to correct issues that produce non-conforming products, low yields, or product quality issues.
5. Works collaboratively with production, maintenance, plant engineers, process engineers, purchasers and other internal staff.
6. Understands and complies with SOPs, Environmental, Health, Safety, and Quality requirements and applicable regulations.
7. Participates in the Safety Program to evaluate manufacturing aspects of safety, responsible as member of Emergency Response Team under the Emergency Response Plan. Promotes safe operating and working procedures.
8. Other duties as required or directed.

SUPPORTIVE FUNCTIONS

In addition to performance of the essential functions, this position may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the manager based upon the particular requirements of the plant:

• Team member for problem solving to resolve production and quality issues.
• Responsible for participation in internal plant audits.
• Participates in cross-training in manufacturing areas of responsibility.
• Responsible as member of Emergency Response Team under the Emergency Response Plan. Promotes safe operating and working procedures.
• Provides support for process improvement teams and capital projects.

SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities:

1. Must have strong verbal and mathematical skills.
2. Must possess writing, communication and interpersonal skills.
3. Strong organizational skills for managing multiple simultaneous tasks/projects required.
4. Proficiency working in a team environment with cross functional groups required.
5. Knowledge of quality system and regulatory requirements pertaining to the production and sale of FDA regulated products preferred.
6. Must learn and understand SOPs, GMP, HACCP and have the ability to complete all required documentation.

PHYSICAL DEMANDS
1. Must be flexible in terms of working hours to meet the requirements of the position.
2. Must be able to fit and wear Personal Protective Equipment (PPE) and attire required to perform duties and assignments.
3. Must have the manual dexterity to install and operate sensors, devices and instruments as required to perform duties and assignments of the position.
4. Must be able to lift up to 65 pounds.
5. Must be able to fit and wear respiratory, hearing, and other personnel protection as required for entry and work.
6. Must be able to fit and wear cleanroom attire as required for entry and work facilities.
7. Must have 20/40 correctable vision.
8. Must be able to sit and/or stand for a minimum of 8 hours per day.
9. Must be able to speak clearly on the telephone.

QUALIFICATION STANDARDS

Education:
Must have a high school or equivalent.

Experience:
1. A minimum of 3 years working directly with manufacturing and packaging equipment and systems or equivalent job experience is preferred.
2. 1-2 years of similar work in Food /OTC Pharmaceuticals manufacturing environment preferred.

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