Contract / Temp to Direct / Direct Hire: Temp to Direct
Country: United States
•AA Degree in technical area and 2 years relevant industry experience OR BS Degree in science or engineering OR 2-5 years relevant industry experience as determined by management
•Moderate knowledge of the scientific principles pertaining to standard processing and manufacturing equipment including, but not limited to, isolators/glove boxes, homogenizers, extruders, pumps, stirred-reactors, lyophilizers, filtration devices, hot oil systems, cooling systems, grinding mills, pelletizers, fillers, etc.
•Excellent written, verbal, and organizational skills
•Capable of authoring and comprehending technical writing
•Ability to execute directions with or without the help of others
•Team player, safety minded
•Fully developed math skills
•Fully developed computer skills
•Excellent interpersonal skills
Job Description This position is responsible for assisting with all aspects of aseptic / terminally sterilized / polymer (clean rooms) and/or non-aseptic (Pilot Plant) processes and procedures for pharmaceutical and/or polymer manufacturing (development/engineering, clinical-phase and/or commercial).
•Demonstrate independent personal proficiency of aseptic technique and the ability to recognize improper technique in others
•Accurately perform complex, multi-step solution preparations with minimal supervision
•Operate PLC controlled equipment with minimal supervision, including adjusting set-points as directed in batch records
•Use basic hand tools and specialty tools as required for equipment operation
•Strict adherence to safety practices and procedures including use of personal protective equipment (PPE) appropriate for the type of hazard and exposure potential
•Actively participate in general area housekeeping
•Perform other duties as required by supervisor
•Perform responsibilities in compliance with the quality systems as described in the Quality Manual
•Adhere to all company safety, health and environmental policies, procedures and directives
•Conduct all development/engineering, clinical-phase and/or commercial batches in a safe manner by use of MSDS to establish chemical hazards; observe the appropriate cGMP procedures; and report all incidents that could threaten the safety of company personnel
•Assemble and disassemble process equipment on multiple unit operations for an extrusion, microsphere, liposome or polymerization process with minimal supervision
•Accurately execute development/engineering, GLP or GMP batch records with minimal supervision
•Seek out and identify opportunities related to the maintenance, calibration, and improvement of company facilities, equipment, and procedures
•Execute in-process environmental monitoring with minimal supervision
•Participate in the execution of IOQs with minimal supervision
•Review and/or revise pertinent SOP’s, forms, etc. as needed
STRATEGIC FOCUS: (The focus desired and expected on the position over the next 1-3 years)
• Short-Term (0-12 months): Assist in achieving departmental, Birmingham Laboratories, Business Line and Business Unit goals and objectives. Safely, environmentally responsibly, efficiently and accurately execute any/all work performed in the Lakeshore Parkway and Tom Martin Drive clean room suites. Support manufacturing-related validation activities.
• Long-Term (12-36 months): Apply aseptic process knowledge/skill set to processes involving higher potency compounds (HPAPIs) and/or more complex aseptic processes. Support above focus areas and begin to take on additional tasks in other groups (time permitting) to grow technical skill set, demonstrate capabilities, broaden knowledge-base of other departmental activities, etc. Begin to outline career path with Production Supervisor to identify areas of interest and opportunities for development in those areas.
Location of Job Birmingham, AL
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