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, Loud Noises (Equipment/Machinery), 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

Job Title: Process Technician I – East

Summary:

Under supervision, responsible for 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.

Job 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. Carry out to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
• Accurately record and analyze against standards all processing data collected 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 resolve 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).
• Coordinate, 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 compliance status required by company and facility standards.
• The job requires employees to work rotating 12-hour shifts with 7 day per week availability and work approved overtime as needed.

Requirements:

• High school diploma or GED required.
• No prior experience required.

Preferred Experience:

• Minimum of 2 years’ experience working in production/manufacturing as an operator or equipment maintenance technician with manufacturing equipment or an associate degree preferred. Experience in a chemical processing or pharmaceutical environment preferred.
• Strong mechanical competence.
• To maintain continued employment, employees hired as full-time employees must successfully complete Phase I of the Process Tech On -The Job Training program within the first 24 months of employment. This will involve learning/applying chemical technology and unit operations, math, chemistry, process equipment and control systems. Experience working with Standard Operating Procedures (SOPs).

    Proficiencies: Good knowledge and understanding of basic equipment. Good problem-solving skills and logical approach to solving problems. Validated interpersonal skills to cultivate the team. Ability to read and interpret technical procedures and governmental regulations. Ability to apply basic mathematical principles. Strong attention to detail and commitments to accomplish the job timely, accurately, and safely the first time is required, as well as the ability to work closely and successfully in a team. 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 Statement: “The above statements are intended to describe the general nature and level of work being performed by people assigned to this job.  They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.”