Work Schedule

Other

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Fluctuating Temps hot/cold, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights

Job Description

Summary:

Working with Pilot Plant Management, support daily operations of cGMP guidelines while coordinating manufacturing, cleaning, and maintenance related activities of the Pilot Plant. 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. Serves as the SME for assigned area.   Makes decisions that require choosing between multiple options or may develop new options to resolve complex problems.

Essential Functions:

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 BOP’s / SOP’s / DR’s or other procedures as the need arises. Apply problem solving skills, in BOP’s and field operations. Lead investigations applying problem solving skills, both in the BOP’s and in field operations and make recommendations for improving Process Operations. Perform manual and computer operations (PLC) to manufacture chemical intermediates and finished products. 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 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; submit samples to QC 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 the need arises. Receive and check raw materials and chemical intermediate deliveries and complete appropriate records in accordance with company procedures (BOP’s/LOM’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 and assist where applicable in skill completion/assessment as the need arises with all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the vital compliance status required by company and facility standards. Responsible for disposing of any hazardous waste generated in accordance with the company’s Hazardous Waste Training but not limited to:

DHEC and EPA Hazardous Waste requirementsHazardous Waste Satellite Area definitions and requirementsHazardous Waste container requirementsEmergency Response Plan

Responsible for transporting full Hazardous Waste Drum(s) from the Pilot Plant Hazardous Waste Satellite area to the less than 90-day Satellite Area. Preferably to be an active member of the Emergency Response Team (ERT).

Education:

High school diploma or equivalent

Experience:

To competently perform this job, a candidate will need the education and experience generally obtained with a high school diploma or equivalent. Successful completion of Phase I, II and III 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 meaningful work experience may be considered

Competencies: Good knowledge and understanding of basic equipment. Good problem-solving skills and logical approach to solving sophisticated problems. Proven, interpersonal and communication skills to champion the team environment. Ability to read and interpret technical procedures and governmental regulations and basic mathematical principles.

Strong attention to detail and strives to accomplish the job timely, accurately and safely the first time is required, as well as closely and optimally 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 and work approved overtime as needed. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Physical Requirements:

Regularly requires standing, walking, stooping, or kneeling for up to 80% of the shift. Lifting up to 50 lbs, climbing stairs, and maintaining focus on detailed tasks are essential.Ability to sit for up to 4 hours, close vision, and adjust focus.

Disclaimer:

This job description is written to present the general content and requirements for the performance of this job. The description does not include a comprehensive list of tasks, responsibilities, or criteria. Managers and supervisors may assign other duties as needed.