Job Description

Maintenance Mechanic

Location: Hicksville, NY

Duration: 15+Months

Hours per day/week: 8/day 40/week Mon-Fri with a two month flex to Tues-Sat schedule

2nd Shift 3 p.m. – 11:45 p.m.

Job Purpose

Ensures the packaging of safe and effective product in an efficient manner. Ensures equipment is installed, set up, and maintained properly. Continuously improves production operations by performing any actions required to support departmental goals while adhering to safety and quality guidelines while reducing costs.

Major Accountabilities

Execute preventive maintenance (PM)/(work order) task lists and ensures proper documentation to maintain FDA compliant operation.

Supports packaging operations as required, performs setups, trouble shoots, documents activities according to procedures, provides updates to GAMED system (as necessary), repairs packaging equipment, and provides other duties as required while maintaining operational efficiency and in a timeframe required to meet departmental expectations and efficiencies. (I.e, schedule adherence)

Disassembles and cleans equipment as needed for efficient and proper line clearance.

Operates machines by performing all necessary challenges and checks as per filling Instructions.

Documents all maintenance, adjustments and repairs in the appropriate logbooks or documents.

Assesses equipment condition and makes recommendations for maintenance activities as required to maintain operational efficiencies and performance.

Assists in Engineering studies, Validation, FAT, Qualifications and provides input to equipment related SOPs.

Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies (i.e. Lock Out/Tag Out), and current Good Manufacturing Practices (cGMPs).

Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency and volume demands while not sacrificing quality or safety.

Maintain effective communication between shifts.

Coordinate with other departments as necessary to maintain efficiency of the lines.

Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).

Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, employee must be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants.

Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.

Key Performance Indicators

Effective preventive maintenance completion of assigned tasks including documentation per preventive maintenance guidelines.

Maintain up time efficiencies by setting up and troubleshooting equipment and working effectively with the production/packaging/quality etc. teams.

Maintain efficient change over times by executing with excellence and teamwork to expedite line clearance procedures.

Support and implement safety initiatives, wearing all personal protective equipment (PPE), and displaying safe work performance according to company safety standards.

Neat and organized work habits.

Capable of multitasking and prioritization of activities to ensure schedule adherence.

Able to work independently and professionally with others while performing any additional actions as necessary to meet departmental and organizational needs as necessary.

Ideal Background

Education :

Associates degree or Technical School diploma and or combination of equivalent experience.

Conceptual understanding of current Good Manufacturing Practices 21 CFR §211.

Experience:

Minimum of two years Packaging Equipment Experience.

Preferred Documentation experience in food, drug, or cosmetics industry.

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