Sr Process Technician

About the Role

Support daily operations of manufacturing MPU per regulatory and cGMP guidelines while coordinating manufacturing, cleaning, and maintenance-related activities. Monitor 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. Make decisions that require choosing between multiple options or developing new options to resolve moderately complex problems.

Responsibilities

• Serve as the subject matter expert in the assigned area, ensuring compliance with all applicable regulatory agencies and company policies and procedures.
• Write, review, and update EOPs 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 while ensuring compliance with regulatory agencies and company policies.
• Monitor all operations of the designated chemical process to ensure safe chemical procedures, quality standards, and compliance with regulatory requirements.
• Adhere to Safety & Environmental guidelines/policies, cGMP, and other applicable regulatory agencies.
• Accurately record and analyze processing data from instruments, DCS, PLCs, Pi, BDR, LIMS, etc., to ensure operating standards are met. Make approved adjustments 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 ensure adherence to specifications such as appearance, foreign substances, and packaging or labeling requirements.
• Receive and check raw materials and chemical intermediate deliveries, completing appropriate records per company procedures (MFPs/EOPs/LOPs/SOPs).
• Administer, document, and maintain Quality Systems conformance to regulatory requirements and company policies through effective utilization of Quality Systems tools.
• Mentor newer process techs, supporting them in learning all required skills and daily job expectations.
• Acquire and maintain QSME (Qualified Subject Matter Expert) certification.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintain the necessary compliance status required by company and facility standards.

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.
• 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).
• Good knowledge and understanding of basic equipment.
• Good problem-solving skills and a logical approach to solving problems.
• Demonstrable interpersonal and communication skills to foster a team environment.
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to apply basic mathematical principles.
• Strong attention to detail and commitment to accomplishing the job timely, accurately, and safely the first time.
• Ability to work closely and effectively in a team environment.
• Ability to apply knowledge of Good Manufacturing processes and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Work Environment

• Able to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Exposure to fluctuating temperatures (hot/cold), loud noises (equipment/machinery), and rapid flashing lights.
• Required use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Exposure to strong odors (chemical, lubricants, biological products, etc.).
• Various outside weather conditions.
• Work with hazardous/toxic materials.
• Working at heights.
• Generally requires the ability to work a 12-hour rotating shift in a 24-hour, 7-day-per-week operation, including evenings and holidays.
• Regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit; and talk or hear.
• Required to walk and stoop, kneel, or crouch approximately 80% of the time.
• 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 include close vision and the ability to adjust focus.

Pay

Competitive hourly pay rate with additional shift differential for 2nd and 3rd shift positions.

Benefits

• Annual performance-based bonus.
• Annual merit performance-based increase.
• Medical, dental, and vision benefits effective on day 1.
• Paid time off and designated paid holidays.
• Retirement savings plan.
• Tuition reimbursement.
• Employee referral bonus.
• Career advancement opportunities.