Shift Technical Advisor

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The primary purpose of the Shift Technical Advisor is to provide the operating shift with real time guidance on operating issues utilizing appropriate chemical, engineering and scientific principles. This position will also utilize problem solving and continuous improvement techniques to improve the overall performance.

·      Essential functional duties of the position

·      Participate in risk assessments

·      Perform training to reinforce and enhance Supervisor and Chemical Operator knowledge

·      Lead troubleshooting and process deviation or incident investigations to identify both direct and root causes and to determine appropriate corrective and/or preventative actions.

·      Review and guide employees to correct errors found in Master Batch Records (MBR) that are in process to drive Right First Time (RFT).

·      Support site continuous improvement activities including identification of opportunities to improve quality, safety and economic performance of the process through proactive engineering evaluation and incident investigation and corrective/preventative action identification and implementation. 

·      Identify, investigate, evaluate, justify and implement process improvements targeted for cost reduction, yield improvement, setup reduction, emissions and waste reduction, energy conservation, cycle time optimization, etc.

·      Coordinate with Process Engineers and support plant changeover from one product to the next in order to meet customer requirements. Conduct training, support start-up, and troubleshoot problems.

·      Prepare, review and/or approve process manufacturing instructions and procedures (batch sheets, special instructions, SOP’s etc.) as necessary to ensure processes are operated safely and under necessary GMP control.

·      Review process changes for impact to EH&S, quality, economics and reliability. Utilize and follow site Management of Change procedures.

·      Facilitate Process Hazard Analysis and risk assessments including tracking action items.

·      Maintain assigned Process Safety Management (PSM) documentation.

·      Knowledge and proficiency skills are required for this position.

·      Engineering degree or similar technical field of study or Equivalent experience.  

·      A familiarity with cGMP quality regulations applicable to pharmaceutical chemical manufacturing is ideal but not required.

·      Strong problem solving and collaboration skills. 

·      Must be able to work in a fast-paced environment while managing multiple priorities.

·      Good written and verbal communication skills are needed.

·      Advanced collaboration and teamwork skills.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee is regularly required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms above shoulder height. The employee is regularly required to climb or balance and stoop, kneel, crouch, and crawl.  Specific vision abilities required in this job include close vision, distance vision, peripheral vision, color vision, depth perception and ability to adjust focus.