Job Description
MAIN TASKS:
- Establish and maintain procedures, tools and methodologies to cover the Jabil contamination control program (clean room monitoring, product monitoring, water monitoring, compressed air monitoring)
- Conduct radiation sterilization validations according to ISO 11137, and establish/maintain the bioburden and dose audit programs
- Maintain knowledge of FDA & ISO Environmental Monitoring and Product Cleanliness guidelines, as applicable
- Conduct technical assessments and support audits as Subject Matter Expert for contract laboratories and critical suppliers
- Conduct risk assessments from a contamination control perspective
- Provide guidance and training to personnel to ensure contamination control program requirements and good manufacturing/good documentation practices are met
- Work with the management to establish plant specific environmental monitoring requirements
- Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy, for obtaining clean and safe products
- Provide input on design of systems to generate processed water
- Support validation of processed Water, controlled environment and finishing/cleaning processes
- Evaluate changes in the manufacturing processes (i.e internal process changes, external process changes, product transfers, etc.)
- Perform compliance tasks (CAPA, Nonconformances, Audit Observations) and support internal and external audits (Tüv, FDA, CFDA, etc.)
- Support projects accross-sites (travel up to 30% to other production sites)
JOB REQUIREMENTS:
- Bachelor or Master degree in Microbiology/Biology
- At least 2 year's work experience in the medical device and/or pharmaceutical industry is a must
- Experience with sterilization of medical devices is an advantage
- Knowledge in Good Manufacturing Processes
- Knowledge in regulations and industry guidelines applicable to cleanrooms (i.e. ISO/EN/AAMI standards) is preferred
- This position requires the ability to interact with managers as well as manufacturing personnel
- This position involves work in cross-functional groups, in an environment that embraces teamwork
- This international company offers employees an environment that encourages talent development
- Business fluency in French and English required, German would be an advantage
Accessibility Accommodation
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.
