Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
- 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 SOPs).
- 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.
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
List certificates (if any) required.
- Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements.
- Must complete training and comply with applicable cGMP requirements.
Minimum number of years of prior experience required to perform job duties.
A minimum of four years pharmaceutical experience in biological manufacturing is preferred.
List specific skills and minimum expertise required to perform job duties
- 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.
Additional Skills:
- 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
Qualifications
- 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
Additional Information
Akriti Gupta
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3409 | Fax: 973.998.2599
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