Miscellaneous Clinical Roles

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 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! At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies. As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for. Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.