Plant technicians with Chemistry Degree are hired at Level 1 as members of a work team. Work teams perform daily bench work, are responsible for ensuring raw materials, packing materials, and finished product are tested according to standards, and determine disposition of materials and finished product to support supply chain need. Work teams conduct problem analyses, investigations, instrument/method troubleshooting, and issue resolution as necessary. Technicians do various types of work to include operating testing equipment, using computers to track/monitor data, perform preventive maintenance on equipment, identify/improve procedures/results, develop individual capability, and help others improve their capability. Technicians are expected to get involved, take charge of situations and confront business-related problems.

The site Microbiologist is responsible for the establishment, maintenance and improvement of the systems used to ensure the microbiological integrity of microbiologically sensitive products. This individual must be able to influence the organization and acts as the site specific expert on all matters pertaining to microbiology, hygiene, and sanitary practices. The role has a considerable amount of technical accountability and interaction with Corporate Microbiology resources.

Must be able to perform a regular site microbiological assessment which covers manufacturing processes, manufacturing environment, raw material receipt and handling systems, process water systems and hygienic practices. The site micro owner will also ensure that the corrective action plans resulting from the assessment are tracked to completion.

Identify potential contamination risks within the systems and determine the appropriate locations and frequency of monitoring to develop a robust daily management system.

Ensure that all relevant personnel are trained to perform aseptic sampling techniques. Define the required microbiological training and include in the sites overall training plan. Build awareness of microbiological risks and control across the site.

Ensure that all the samples are tested according to specified methods and devise a system to ensure full traceability of the samples. Provide technical coaching and direction setting for outside labs.

Routinely review the data produced by the daily management systems and provide technical coaching for action by the production leaders. Establish appropriate action levels and define the required actions when these levels are exceeded.

Become the primary site resource to review and approve new equipment and facility design related to new microbially susceptible products. Train the site maintenance/engineering staff in the basics of clean design.

Become part of the startup team for new products involving microbiologically susceptible products. Assist in the definition and execution of the appropriate validation protocols defined in the sites validation plan to prove the effectiveness of the cleaning and sanitization procedures.

Provide technical coaching to the site leaders to help them differentiate between major and minor contaminations and recommend appropriate actions to deal with both. Be able to define the corrective actions to eliminate the current contamination and prevent any re-occurrence. Lead the root cause investigation of any microbial quality incidents. Ensure that any micro contaminant is identified as a means of locating the source of the contamination.

Consult with corporate micro resources on ways of improving the cleaning and sanitization procedures.

Lead the site in the establishment and implementation of relevant good sanitary practices and procedures related to the manufacturing process.