Sterile Material Handler, 2nd shift


Job ID 18-00025

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Summary:
The purpose of the Sterile Material Handler is to assure sterile commodities are delivered into the sterile filling area in an aseptic manner per the governing SOP's.  Commodities should be aseptically received in the filling area in a timely fashion to assure continuation of the production fills.  The Sterile Material Handler is responsible for the following duties:
Essential Functions:
Deliver sterile materials into the cleanrooms.
Empty the autoclaves
Receive commodities from the ware house and pass into the cleanroom via the material in pass thru
Remove equipment and commodities from the cleanroom at the end of a production run autoclave
Must be detail oriented with the ability to work within a team environment or independent if required.
Become and remain gown qualified.
Disinfect, deliver and stock gowning components to the gowning room.
Prepare, weigh and package raw materials (powder) for contract sterilization.
Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing.
Perform reconciliations of components, drug products, and associated materials as per defined procedures.
Follow aseptic gowning procedures.
Participate in the end of fill process including weighing, recording and attaching data or records to batch record.
Set up/preparation/ cleaning and autoclaving components used in aseptic manufacturing operations (some lifting required, up to 55-60 lbs.) 
Some Saturdays,  Sundays and weekly overtime will be required to work by the company based on the department's schedule.
Cleaning and sanitization of the aseptic production areas, including filling room sanitization between runs.
Must document sanitization activities in log books, forms etc. in a legible manner as per the cGMP.



Qualifications

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed are representative of the knowledge, skill, and/ or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

Education and Experience:
High School Diploma or GED required with 3-5 years' experience in Pharmaceutical manufacturing. 
 

Job Prerequisites:
Read write and speak the English language fluently.
Strong communication skills.
The ability to manage multiple operations, simultaneously during routine duties.
Understanding of the metric weight system. 
While performing the duties of this job, the employee is regularly (more than 50%) required to stand, walk, stoop, kneel, crouch or crawl.  The employee is frequently (25% to 50%) required to use hands to finger, handle or touch, reach above shoulders, talk or hear and taste or smell. The employee must occasionally (up to 25%) sit, and climb or balance.   The employee must regularly lift and/or move up to 10 lbs and frequently lift and/or  move  up to 25 lbs and occasionally lift and/or move up to and more than 60 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
 

Candidate Details:
1+ to 2 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - High School Diploma or Equivalent
Willingness to Travel – Never