Thermo Fisher Scientific Process Technician 1 in Florence, South Carolina

Job Description

Summary:

Under supervision, monitors all operations of 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 involve direct application of technical knowledge.

Essential Functions:

Operate automated and manual chemical process equipment and conduct associated activities such as sampling, chemical/material handling, cleaning and maintenance in accordance with Standard Operating Procedures, current Good Manufacturing Procedures and Safety guidelines.

Maintain a clean and safe process area.

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.

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.

Education:

High school diploma or equivalent

Experience:

To competently perform this job, a candidate will need the experience generally obtained through high school diploma or equivalent. Will require successful completion of Phase I of the Process Tech On -The Job Training program/process involving learning/applying Chemical Technology, Math and Chemistry or must have equivalent experience in the pharmaceutical industry.

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies: 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 drive 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. This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Physical Requirements:

Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, or hear. The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time. The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours. Specific vision abilities required by this job include close vision and ability to adjust focus

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.