Manufacturing Technician

Job Title : Manufacturing Technician (12-hr rotation NIGHT)

Location : Durham, NC

12 + months contract

Job Description

Candidates need to be able to work a 7P m -7 : 30A m rotation shift. One week you will work four days Monday - Thursday and the next three days Monday - Wednesday.

Overtime availability once fully trained.

Summary :

The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT / ALERT bottles and / or preparing and formulating the liquid reagents that fill the finished BacT / ALERT bottle in a cGMP compliant manner.

Roles and Responsibilities :

Production Manufacturing & Packaging : Operate high speed manufacturing

equipment, in some cases highly automated, using HMI / SCADA interfaces

Filling : chemical weighing and reagent formulation

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

Provide assistance with the review and revision of Manufacturing Directions and SOPs

necessary for the manufacture and packaging of product.

Assist with manufacturing deviation analysis, CAPA actions and other process

equipment related quality concerns

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

compliance with cGMP requirements

SafetyComply 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 DutiesGenerate reports, charts and KPI's and interpret the data to identify

problems, and proceed with proper decision making

Assist with executing validation protocols associated with manufacturing / packaging

equipment and procedures including revalidation as scheduled or required to

maintain systems in a validated state

Perform computer applications

Perform other duties as assigned by Management

Experience, Skills and Qualifications :

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

Skills Certification in Bioworks Program preferred

For Manufacturing and Packaging Demonstrated proficiency in the operation of high

speed, highly automated, production equipment preferred.

For Filling Background in Bulking and / or compounding in food, supplement, cosmetic,

medical device, or pharmaceutical chemical formulation is desired.

Familiarity with measurement scales, mixing, blending, chemical mills and other

formulation manufacturing equipment strongly desired.

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.

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

Ability to regularly climb stairs to perform work.

Ability to routinely lift 20-40 lbs.

Ability to stand for extended periods of time on shifts that could range from 8-12

hours.

Ability to operate motorized pallet jacks.

May be exposed to and require the handling of chemicals, antibiotics and / or

hazardous materials.

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

Lab work is performed wearing various types of PPE which include but is not limited

to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves,

PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas

of Manufacturing.

Ability to maintain reliable and punctual attendance

Ability to work overtime as required to support a 24 / 7 production operation