Location:West Chester, Ohio, United StatesJob reference:
Nov. 03, 2016
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Packaging Mechanical Technician in West Chester, Ohio, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities
The Mechanic Technician is a position reporting to a Process Execution Team Facilitator, which supports Bulk/Diluent, Filling/Inspection, and Packaging operations. The position entails the execution of setup, changeover, repairs and preventative maintenance for all equipment used in the production processes in various Classified/Non-Classified areas. It requires the ability to perform mechanical and electronic troubleshooting in order to ensure optimal operation of equipment via OEE. The Mechanic Technician will also perform basic mechanical training to Technicians and serve as a resource to implementation of continuous improvement projects. Essential Job Functions:
- Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
- Perform 5S activities and maintain organization of operating areas.
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.
- Be familiar with “Material Safety Data Sheets” for area chemicals.
- Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed.
- Knowledge of product security controls including controlled substance handling.
- Responsible for outgoing quality level.
- Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET.
- Work with minimal supervision under the direction of the Maintenance Facilitator, Process Facilitator, Engineer, or other activity lead.
- Perform roles of Technician as required to support daily PET activities.
- Complete emergency repair, rebuilding, changeover and inspection work on production and related equipment. Install, inspect, test, adjust, repair and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner. Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs.
- Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
- Set-up equipment and perform required adjustments to ensure each operation is performing per process specifications. Provide training to operators for equipment set-up and for minor adjustments or repairs.
- Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs.
- Responsible for OEE performance of all equipment and systems within the assigned operating area.
- Follow and maintain compliance with established MRO procedures and inventory control.
- Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities.
- Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas.
- Perform other similar and related responsibilities as assigned by area management.
- High school graduate, vocational school graduate or equivalent
- Minimum three years experience in a regulated production environment, specifically responsible for equipment maintenance and performance
- Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
- Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair.
- Associates in Engineering or a related discipline or equivalent mechanical trade school graduate preferred
- Previous experience with automated equipment preferred
- Training in other technical disciplines including; refrigeration technology, vacuum technology, programmable logic controllers, freeze drying, blow-fill seal applications preferred
- Training in mechanics, hydraulics, electronics and testing equipment in electrical and/or mechanical troubleshooting
- Knowledge of data and materials maintenance systems such as SAP, KRONOS, or otherMRP
- Experience with OEE, TPM, LEAN or other Continuous Improvement systems
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.