Sterilization Process Operator in Somerville

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Job DescriptionJob Description

JOB SUMMARY

We seek to hire an exceptional Sterilization Process Operator to help us realize our ambitious growth goals. This individual will report to the Process Supervisor or Operations Manager and is responsible for monitoring the sterilizer system which includes observing pressure, temperature and relative humidity measurements on charts or computer monitors. They will also ensure that customers’ products are moved through the facility at the appropriate times, which include safely handling product before and after the sterilization process, ensuring that product flow, documentation, and safety protocols are maintained in compliance with the standard operating procedures (SOPs) and applicable standards (ISO 13485 and 21 CFR Part 820).

PRIMARY FUNCTIONS

1. Monitor and operate sterilizer systems, ensuring correct cycle parameters are achieved and maintained throughout the cycle.
2. Observing pressure, temperature and relative humidity measurements on charts or computer monitors
3. Adjust controls, valves, and system settings in accordance with validated process specifications and SOPs.
4. Perform pre-cycle setup and post-cycle unloading activities, including verifying product identification, load configuration label creation and palletization.
5. Report any abnormal system performance or alarm conditions promptly to the Process Supervisor immediately.
6. Documenting and recording process readings
7. Document all process readings and cycle data accurately in the batch records, logbooks or electronic data systems as needed, and ensure all processing documentation is complete, accurate and compliant with company standard operating procedures and applicable standards.
8. Turning valves and adjusting controls to ensure the safe operation of the equipment
9. Observing sterilizers and auxiliary units to detect malfunctions and assisting with repairs as needed
10. Report system problems to the Engineering team and assisting with troubleshooting, repairs and requalification activities as needed.
11. Performing some daily and weekly equipment preventative maintenance tasks and may assist Maintenance as required and maintain cleanliness and orderliness of the sterilization and staging areas to support cGMP and safety requirements
12. Unloading as well as packaging and shipping of product
13. Reporting any damaged product to the Process Supervisor/Manager
14. Storing and removing chemicals used in processing in accordance with established procedures and laws
15. Participates in plant safety committees and follows all established safety rules and regulations
16. Actively identify and propose enhancements to processes, systems or procedures to drive continuous improvement.
17. Assists with other tasks as assigned by Supervisor

SKILLS & QUALIFICATIONS

1. High School Diploma or GED required; Associate degree in technology (mechanical, electrical, HVAC etc.) .
2. Minimum of six (6) months to one (1) year of experience working in a sterilization/chemical environment
3. Must be willing to work established shifts (as well as overtime as needed)
4. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, fractions and decimals
5. Must have forklift driving experience
6. Must be able to read, write, and speak fluent English
7. Experience with mechanical devices, tools, and testing equipment required.
8. Utilize technology (laptop and computer software (Microsoft Office)) to perform administrative duties as required.
9. High level of professionalism accompanied with excellent interpersonal and customer service skills.
10. Must have excellent time management skills, being able to prioritize multiple priorities at one time.
11. Ability to work in a fast-paced environment with the flexibility to adjust to and meet changing priorities.
12. Make good business judgments and decisions in relation to efficiency and effectiveness while meeting daily service expectations.
13. Must have the ability to evaluate situations, good problem-solving skills, and prioritize factors in decision making.
14. Must be dependable and punctual.
15. Maintains a positive attitude and a strong work ethic.
16. Must be authorized to work in the United States

ESSENTIAL FUNCTIONS/PHYSICAL REQUIREMENTS

1. Must be able to regularly lift and move up to 25lbs.
2. Frequently lift and move up to 50lbs.
3. Occasionally lift and move up to 100lbs.
4. Push/pull weights of 100lbs +
5. Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk and hear.
6. Must be able to crouch, stoop, or squat to work inside or under equipment, or move through low headroom spaces.
7. Abe to occasionally work in tight spaces.
8. Must climb ladders and/or scaffolds and work above floor height.
9. Requires routine pushing, pulling, grasping, and manual dexterity in the use of hands, arms and shoulders.
10. Occasionally exposed to wet or humid conditions, fumes and airborne particles, and outdoor weather conditions.
11. Distance vision/peripheral vision, depth perception, and ability to adjust focus.
12. Must be able to sit and drive for long periods of time during travel.
13. Must be able to occasionally walk great lengths at a time and stand for extended periods of time.
14. Must be able to perform work from floor level to above shoulder height if needed.
15. Must be able to operate a computer and other office machinery such as a calculator, copy machine and printer.

EOE/AA/M/F/Veteran/

Benefits

• Medical Insurance
• Dental Insurance
• Life Insurance
• Short Term Insurance
• Paid Vacation
• 401(k) Retirement Plan with company match

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