Production Line Operator - Sterile Filler


Job ID 18-00006

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Production Line Operator - Sterile Filler - 466BR 
6 Openings
Security Clearance Required: No
Visa Candidate Considered: No
Full-time Benefits - Full
Relocation Assistance Available - No
Commission Compensation - No
Bonus Eligible - No
Overtime Eligible - No
Interview Travel Reimbursed - No
 
SCREENING QUESTIONS:
Do you have sterile experience and gowning qualifications in Pharmaceutical Manufacturing?
 
IDEAL CANDIDATE:
Sterile filling experience necessary.
 
CANDIDATE DETAILS:
1+ to 2 years' experience
Seniority Level - Entry
Management Experience Required - No
Minimum Education - High School Diploma or Equivalent
Willingness to Travel – Never
 
SUMMARY:
All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.
 
ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
Must be detail oriented with the ability to work within a team environment or independent if required.
Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required.
Operate clean room machines aseptically and efficiently (Kalix ointment tube filler, Chase-Logeman bottle filler)
Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing
Prepare, weigh and package raw materials (powder) for contract sterilization
Make Isopropyl Alcohol 70%, Veshpene  and LpH as disinfectants used in Aseptic Manufacturing
Must disinfect, deliver and stock gowning components to the gowning room
Maintain aseptic gowning qualification
Perform reconciliations of components, drug products, and associated materials as per defined procedures.
Follow aseptic gowning procedures.
Dispose of waste after filling process is finish: 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.)  Any object greater than 60 pounds, not to exceed 100 lbs. must require the use of a buddy system.  This system requires two employees to lift the object. No employee can lift any object greater than 60 lbs. by themselves.
Some Saturdays and Sunday (Overtime) will be required to work by the company based on the department's schedule.
Must assume any position required within the department for coverage.
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 cGMP.
Must be able to work until all cleaning activities are complete.
Must be flexible in adapting to a work schedule that could change as a result in business direction.
 
ADDITIONAL RESPONSIBILITIES:
Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.



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 or Associate's Degree and equivalent job experience in Pharmaceutical Manufacturing.