Senior Process Associate Jobs in Highland Heights, KY

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&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 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 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).

• Equivalent combinations of education, training, and relevant work experience may be considered based on the above requirements.
   

Knowledge, Skills, Abilities

• 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 drives 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.

• Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
   

Physical Requirements / Work 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.

• 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.
   

What We Offer

Compensation

• Competitive Hourly Pay Rate

• Additional shift differential for 2nd shift and 3rd shift positions

• Annual performance-based bonus

• Annual merit performance-based increase

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

• Employee Referral Bonus

• Career Advancement Opportunities