Job Details

Department:

Packaging

Job Title:

Packaging Mechanic

FLSA Status:

Non-Exempt

Reports To:

Packaging Supervisor

1. Role Purpose:

Mechanics are responsible for the setup, operation, adjustment and repair of pharmaceutical packaging equipment. This position reports to the Packaging Supervisor.

2. Key Duties & Responsibilities:

• Ensure the proper set-up and operation of standard packaging equipment such as (but not limited to) Unscramblers, Fillers, cottoners, Desiccant Feeders, Induction Sealers, Re-torquers, Labelers, outserters and Tape Machines.
• Maintain proper operation of equipment to accurately and efficiently perform the designed functions.
• Perform preventive maintenance of equipment as required.
• Perform changeover of equipment for packaging of different products and components including size or format changes.
• Perform packaging line equipment setup per qualified ranges and document the parameters in setup sheet.
• Troubleshoot and correct mechanical problems as they occur.
• Ensure proper execution of Master Batch Records, standard operating procedures and validation protocols.
• Ensure accurate completion of equipment logs and/or lab notebooks.
• Ensure cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
• Interface and consult with Group Leader and Quality Assurance personnel.

Identify and report quality issues.

• Maintain compliance at all times by following batch records, SOPs and all company policies.
• Cleaning and sanitization of manufacturing rooms including walls, floors, and ceilings per current SOPs
• Report accidents and unsafe conditions or unusual circumstances to supervisor.
• Understand and adhere to all cGMP and FDA regulations.
• Assist in the training of others.
• Maintain a neat and orderly work area at all times.
• Other duties as assigned or delegated
• Comply with FDA guidelines/Company Policies of Data Integrity

3. Education & Experience:

High School Diploma or equivalent or technical school certificate preferred

4. Technical competencies/ Certifications/ Licenses:

• Excellent mechanical aptitude.
• 1-3 years’ experience as a packaging mechanic or previous experience working in a regulated environment (GMP or FDA) preferred.
• Must be able to competently setup, adjust, repair and maintain equipment in a timely manner.
• Excellent written and verbal communication skills.
• Ability to read and comprehend SOP’s, Batch Records and training documents.
• Ability to multi-task effectively.
• Excellent interpersonal skills and ability to effectively interact with different functional groups.
• Must be able to stand for an 8-hour shift and lift, push or pull up to 50 pounds.
• Must be able to properly complete documentation including maintenance forms and equipment logbooks.
• Ability to wear any type of protective equipment.
• Practical experience in the troubleshooting and repair of packaging equipment is highly desired.

5. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.