Production Technician

Job Description

Job Description

Position Description :

Description :

1st shift (0700 - 1530)

Mon to Fri

Must have previous isolator experience.

Position Overview :

This is a mid-level position in the aseptic filling groupwithin the Manufacturing department. It utilizes

those with experience and the training needed tomanufacture pharmaceuticals in a strictly controlled

GMP environment. The employee will progress through anumber of job functions and be required to

demonstrate increasing skill levels while demonstrating leadershipcapabilities.

Major Position Activities & Responsibilities :

Become certified for entry into the GMP cleanroom spaceto be able to perform sanitization, stock / replenish supplies, equipment set up,and all related aseptic filling operations.

Execute aseptic fill processes using batch records andSOPs.

Responsible for verifying the calibration of all relatedequipment and sanitization of supplies to support production.

Increasing level of competency in the manufacturing areaprocedures. Assigned job duties will include Aseptic and clean room areas,Component Preparation, Capping, and Packaging.

Learn the functions necessary to work in the fill suite.This will include the operation of the associated equipment.

Ability to perform tasks with minimal supervisordirection.

Provide training of new team members.

Able to understand the manufacturing schedule andcoordinate tasks to achieve the schedule.

Provide floor leadership in the absence of supervisor orPT3 technicians.

Transport and / or dispose of hazardous chemicals.

Perform all other duties as assigned.

Must immediately notify supervisor if affected byinfectious disease or open lesions on body, as individuals are not permitted toenter manufacturing areas or handle product if these conditions exist.

Scope :

This position has no direct reports.

Background Qualifications :

High school diploma or the equivalent. College coursework preferred

Minimum 3-5 years including relative aseptic fillingexperience in a cGMP pharmaceutical manufacturing facility.

Must possess working knowledge and understanding of GMPcompliance regulations.

Must possess knowledge and experience in the asepticfilling process along with equipment cleaning, preparation and assembly.Experience in stopper prep, capping and packaging preferred.

As persons in this role are engaged in the openmanufacture of medicinal products, individuals must not be affected by aninfectious disease nor have open lesions on any exposed surface of the body.

Must be able to comprehend and follow detailed proceduralinstructions in written and verbal form.

Must possess adequate working knowledge of arithmeticfunctions to accurately perform or check calculations required in the productdocumentation.

While performing the duties of this job, the employee isregularly required to use their hands and arms. The employee is frequentlyrequired to stand. The employee is occasionally required to sit; walk; stoop,kneel, bend, crouch, or crawl, talk or hear. The employee must regularly liftand / or move up to 10 pounds, frequently lift and / or move up to 50 pounds.Specific vision abilities required by this job include close vision, distancevision, color vision and peripheral vision.

Must possess fluent English (written and verbal) skillsin order to read, comprehend, and communicate GMP compliance documentation aswell as Standard Operating Procedures.

Computer skills in Microsoft Office such as Word andExcel are a plus.