Job Description & How to Apply Below
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, Loud Noises (Equipment/Machinery), Rapid flashing lights, 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, Will work with hazardous/toxic materials, Working at heights
Job Description
Discover Impactful Work:
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.
A Day in the Life:
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.
Must be able to operate a lift truck.
Perform P&.
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.
Keys to Success:
Education
High school diploma or equivalent.
Experience
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…
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