Miscellaneous Clinical Roles

• The person filling this position operates all equipment in two assigned Manufacturing areas.
• He or she will also clean equipment and facilities, and provide documentation of all duties in accordance with Good Manufacturing Practices.
• Incumbent will perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.
• The incumbent will be required to attend quality-training programs and orientations on an annual or as needed basis.
• This individual will be required to become familiar with domestic and international regulatory requirements associated with manufacturing and biological processes.
• Annual performance goals and objectives will be evaluated against specific quality performance requirements as defined by the Manufacturing Supervisor.
• Mandatory commitment to report to management any potential or actual deviations from regulatory requirements.
• Ongoing input regarding quality process improvements.
• Master documentation procedures by following detailed written and verbal instructions in order to complete assigned tasks (follow area SOP’s).
• Demonstrate knowledge of procedures by performing tasks and duties and maintaining detailed records in a manner compliant with cGMPs.
• Perform routine job duties, which may include vacuuming, mopping ceilings, walls and floors, emptying trashcans, etc.
• Prepare production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens.
• Clean and sterilize process equipment (tanks, fermentors) as needed.
• Demonstrate and instruct proper gowning and aseptic processing procedures.
• Work with individuals as a team.
• Work various shifts and some weekends.
• Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor.
• Train new employees on production processes.
• Perform lab work, such as: performing sample dilutions, pH, and conductivity readings.
• Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis.
• Basic understanding of the metric system.
• Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns.
• Must possess mechanical ability to assemble and operate equipment.
• Must pay attention to detail by following procedures and noting unusual conditions.
• Must have written and oral communication to read procedures, write accurate observations and follow directions
  

The following combinations of education and work experience are considered acceptable:

• BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience
• AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience
• HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience
• Or progression from Bio-processing Technician Level I that includes additional internal development curriculum
• A minimum of four years pharmaceutical experience in biological manufacturing is preferred.

Additional Skills:

• GMP experience required
• Pharma experience highly preferred
• Bioprocessing experience in a cGMP environment
• Knowledge of Clean and Steam in Place Systems
• Perform facility cleanings, collecting WFI and Clean Steam samples.
• Experience with autoclave and industrial washers.
  

All your information will be kept confidential according to EEO guidelines. 

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.

If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!