Job Description

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

Packaging Line Mechanic III is a senior-level technician responsible for the expert-level maintenance, troubleshooting, and repair of complex pharmaceutical packaging equipment, including high-speed automated systems and for providing maintenance support to our facility. This role involves performing extensive preventative maintenance, complex mechanical and electrical repairs, equipment setup and changeovers, and guiding other operators, all while strictly adhering to cGMP (Current Good Manufacturing Practices) and company protocols to ensure product quality and regulatory compliance. Using a variety of hand and power tools, perform defined inspections and assigned preventive maintenance functions

MAJOR DUTIES AND RESPONSIBILITIES:

• Organize and prioritize workflow and labor for all mechanics on production floor.
• Responsible for maintaining good operating conditions of machinery used in the manufacturing work area and systems assigned.
• Cleans and organizes work area according to production and safety standards.
• Repairs and maintain machinery and equipment used in the manufacturing process according to standards.
• Performs format changeovers on equipment from set up sheets, documents and equipment manuals to accommodate various products.
• Participates in the creation of set up sheets and documents.
• Performs preventive maintenance inspections and prepares inspection reports concerning operation of equipment and mechanical condition of equipment.
• Participate in the establishment of new equipment and the improvement of existing process equipment.
• Responsible for performing assignments in conformance with appropriate Regulatory (cGMP’s) and departmental Standard Operating Procedures which assure the quality of our products.
• Documents all work performed comply with acceptable current Good Manufacturing Practices (cGMP) standards.
• Helps to attain goals of the maintenance department and the facility by contributing ideas and suggestions.
• Contributions to the production of a quality product which requires quality equipment maintained and updated by the maintenance department.
• Uses critical thinking skills to determine possible causes of equipment failure.
• Responsible for communicating with employees and management as to potential problems that need addressing or opportunities that may be acted upon.
• Must be a self-starter and have the initiative to create work when the daily tasks are completed.
• Assumes other duties and responsibilities as required.

QUALIFICATION:

Required

1. Strong background in electrical, mechanical, and packaging/ process equipment.
2. Working knowledge of cGMP and associated regulations is required.
3. Ensure all activities comply with company policies, Standard Operating Procedures (SOPs), and cGMP regulations to maintain product integrity and quality standards.
4. Must be able to troubleshoot equipment in a timely manner.
5. Must have working knowledge of PLC programs, a strong background in electrical, mechanical, and machine shop.
6. Must have excellent documentation and verbal communication skills. Ability to read and interpret equipment manuals, work instructions, and schematics.
7. Must possess the ability to work independently and effectively with peers and display strong interpersonal and organizational skills.

Preferred Additional

1. Possess significant experience (2-3 years minimum) as a packaging mechanic or technician in a pharmaceutical or regulated manufacturing environment.

CRITICAL SKILLS AND ABILITIES:

• Able to work well with others and give written/verbal instructions to other mechanics on the floor.
• Able to give clear written and verbal responses to supervisor and members of management.
• Extra considerations offered to candidates with prior experience in the aerosol industry.
• Extra considerations offered to candidates with cGMP, FDA and/or medical device experience.
• Ability to lift 35-50 pounds on a regular basis.
• Ability to stand for long periods of time on a regular basis.
• Can work in/around/under/over equipment safely and with the ability to diagnose and repair on the job.

Education and/or Training

Technical Skills and Experience

Proficient in the use and knowledge of PCs.

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