Maintenance Technician, Filling - Operations
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Maintenance Technician is a position reporting to a Process Execution Team Technical Manager, 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 areas up to a Class 100 aseptic environment. It requires the ability to perform mechanical and electronic troubleshooting in order to ensure optimal operation of equipment via OEE. The Maintenance Technician will also perform basic mechanical training to Production or Preparation Operators 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.
- 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 Technical Manager, Process Facilitator, Engineer, or other activity lead.
- Perform roles of Technician and Mechanical 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 diploma or GED required
- Minimum 2-3 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
other MRP systems
- Experience with OEE, TPM, LEAN or other Continuous Improvement systems
Internal/External Contacts & Customers:
- PET staff
- Vendors, Suppliers, and Contractors
- Strong verbal and written communication skills
- Proven ability to work effectively in a team environment
- Strong mechanical/technical aptitude
- Ability to interpret technical documents
- Candidate should possess the ability to work in a changing/demanding environment
Direct Reports- 0
Indirect Reports- 0
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.