Sr Process Technician

Thermo Fisher Scientific•Florence, SC

5d•Onsite

About The Position

Working with Manufacturing Management, support daily operations of manufacturing MPU per regulatory and cGMP guidelines while coordinating manufacturing, cleaning, and maintenance related activities of the MPU. Monitors all operations of the designated chemical process to ensure safe chemical procedures, quality standards and compliance with regulatory requirements for working with and handling raw materials, production intermediates, and final products. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems.

Requirements

High school diploma or equivalent.
Minimum of 4 years’ experience working in production/manufacturing as an operator or equipment maintenance technician with manufacturing equipment or an associate degree required.
Experience in a chemical processing or pharmaceutical environment preferred.
Successful completion of Phase I, II and III of the Process Tech On-The Job Training program/process involving learning/applying chemical technology and unit operations, math, chemistry, process equipment and control systems.
Experience working with Standard Operating Procedures (SOPs).
Equivalent combinations of education, training, and relevant work experience may be considered based on the above requirements.
Good knowledge and understanding of basic equipment.
Good problem-solving skills and logical approach to solving problems.
Demonstrable interpersonal and communication skills to foster the team environment.
Ability to read and interpret technical procedures and governmental regulations.
Ability to apply basic mathematical principles.
Strong attention to detail and drives to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment.
Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Nice To Haves

Experience in a chemical processing or pharmaceutical environment.

Responsibilities

Serve as the subject matter expert in area of assigned responsibility, ensuring compliance with all applicable regulatory agencies, as well as company policies and procedures.
Write/Review/Update EOP’s or other procedures as required.
Operate a lift truck.
Perform P&ID updates.
Lead investigations apply troubleshooting problem solving skills, both on the DCS and in field operations and make recommendations for improving Process Operations.
Perform manual and computer operations (PCR-2A and PLC) to manufacture chemical intermediates and finished products ensuring compliance with all applicable regulatory agencies, as well as company policies and procedures.
Monitor all operations of designated chemical process to ensure safe chemical procedures, quality standards and compliance with regulatory requirements. Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
Accurately record and analyze against standards all processing data gathered from instruments, DCS, PLC’s, Pi, BDR, LIMS, etc. to ensure operating standards are met. Make approved adjustments as appropriate to maintain process parameters within designated limits.
Make recommendations regarding improving process operations.
Obtain samples of process streams or products in accordance with company procedures; submit samples to IPC Lab or perform tests to determine specific properties; Record/analyze results and take appropriate action.
Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required.
Receive and check raw materials and chemical intermediate deliveries and complete appropriate records in accordance with company procedures (MFP’s/EOP’s/LOP’s/SOP’s).
Administer, document and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions.
Mentor newer process techs, support them in learning all skills needed and daily job expectations. Acquire and maintain QSME (Qualified Subject Matter Expert) certification.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.