Manufacturing Technician

Normal working hours for this role are 7 : 00am - 3 : 30pm working a Monday thru Friday schedule.

Position Summary

Individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks and Material reconciliation that goes along with the batch.

Primary Responsibilities :

Production :

Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs

Quality :

Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner

Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations

Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.

Safety :

Comply with all safety policies and procedures at all times

Appropriately use PPE (Personal Protection Equipment)as required to perform routine and non-routine duties.

Other Duties :

Perform computer applications

Perform other duties as assigned by Management

Skills :

Certification in a Bioworks Program or equivalent is preferred

Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.

Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.

Knowledge of FDA and / or GMP regulations preferred.

Mechanical background preferred.

Ability to rapidly learn new procedures and reduce them to practice.

Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

Education :

High School Diploma or GED

Knowledge and Experience :

Minimum of 0-1 years of relevant experience in a regulated production / operations environment

Additional Information :

Performs all job functions and responsibilities in a safe and responsible manner.

Excellent personal hygiene required.

Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Ability to operate motorized pallet jacks or forklift.

Ability to remain to stand for long periods of time

Lifting, pushing, and pulling may be required for stocking and movement of equipment.

May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away

May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and / or hazardous materials.

May be exposed to strong odors incurred during media production or other operations.

Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.

Ability to stand for long periods of time

Ability to lift between 50-100lbs

Ability to push / pull up to 150+lbs