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 Filling Environmental Monitoring Technician
in West Chester, OH
, you'll play a pivotal role in channelling 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 ResponsibilitiesAs the Filling Environmental Monitoring (EM) Technician you will be reporting to a Process Execution Team (PET) Facilitator, which supports Filling PET operations. The position entails the setup and execution of environmental monitoring in support of production operations. It requires the ability to understand critical operations in production, and perform sampling requirements per standard operating procedures. Once tenured in role, the Filling EM Technician will also provide basic EM training to other Technicians and serve as a resource for implementation of continuous improvement projects.
- Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.
- Perform environmental monitoring in all manufacturing and support areas.
- Submit EM samples for testing.
- Perform EM data entry for review and analysis.
- Participate in investigations resulting from EM excursions.
- Train others in environmental monitoring techniques and principles.
- 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 Process Facilitator.
- Perform roles of Technician as required to support daily PET activities.
- Complete emergency repair, rebuilding, changeover and inspection work on production and related equipment.
- Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic and environmental 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.
- 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.
- Perform 5S activities and maintain organization of operating areas.
- 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.
- 1-2 years advanced education beyond high school
- Minimum three years' experience in a regulated environment
- Ability to work 12 hour shifts including every other weekend
- Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language
- Experience with computer based software systems
- Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair
- Strong verbal and written communication skills
- Proven ability to work effectively in a team environment
- Self-starter that has ability to work effectively independently
- Strong mechanical/technical aptitude
- Ability to interpret technical documents
- Candidate should possess the ability to work in a changing/demanding environment.
Internal/External Contacts & Customers:
- Bachelors in Science related discipline
- Previous experience with automated equipment preferred
- Training in mechanics, hydraulics, electronics and testing equipment in electrical and/or mechanical troubleshooting
- Knowledge of data and materials maintenance systems such as MODA, SAP, KRONOS, or other MRP systems
- Experience with LEAN or other Continuous Improvement systems
- Experience in Aseptic Processing
- Experience in Environmental Monitoring
- PET staff
- Vendors, Suppliers, and Contractors
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 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.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca