Packaging Mechanic - 2nd Shift

The Packaging Mechanic sets up packaging and labeling equipment area pursuant to guidelines established in the job order and SOPs. He/she is also responsible for repairs and preventative maintenance on all packaging and labeling machinery.

ESSENTIAL DUTIES AND RESPONSIBILITIES
 Identify and remove safety hazards.
 Perform and documents required and preventative maintenance on all machinery.
 Troubleshoot and makes necessary adjustments and/or repairs to packaging and labeling equipment.
 Assemble, disassemble and reassemble packaging equipment, change parts and tooling in a timely manner.
 Determine that packaging and labeling equipment is in proper operating order so that Operations may proceed.
 Maintain inventory of packaging and labeling equipment, change parts and tooling.
 Assist in performing IQ/OQ for packaging and labeling equipment as required.
 Assist in preparation of IQ/OQ protocol and reports.
 Liaise with Purchasing, Production, Planning/Scheduling and Quality Control as needed with respect to packaging and labeling equipment.
 Provide written documentation as required and keeps complete record files to document all projects, changes, deviations and modifications.
 Provide information to supervisor and team members by preparing and submitting progress reports as appropriate
 Recognize deviances and alerts supervisor while demonstrating ingenuity by offering suggestions and recommendations.
 Learn and follow policies, procedures, SOPs, GLPs/cGMPs, safety guidelines and the like pertinent to the execution of duties.
 Report issues that are out of specification, problems and unsafe conditions to management.
 Ensure compliance is maintained in all areas of responsibility.
 Assist in other parts of the department as workload and project priorities dictate.
 Adhere to policies and processes to ensure all quality standards are in compliance with FDA regulations and ISO standards.
 Adhere to set safety standards.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 High School Diploma or equivalent.
 Minimum 1 year prior experience with pharmaceutical production equipment preferred.
 Demonstrated ability to work independently, handle multiple tasks simultaneously and meet critical timelines.
 Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
 Knowledgeable of cGMPs, FDA , DEA and OSHA Regulations and ISO guidelines.
 Strong ability to contribute and function in a team environment to achieve Company goals.
 Working knowledge of personal computers and Microsoft Office Products, including Word and Excel.