Purpose
To ensure the site's cleanroom and environmental control systems meet regulatory and global standards by leading environmental monitoring, risk assessments, and validation activities that support compliant and continuous manufacturing of medical devices.
Responsibilities
* Complete gap assessment between local legacy procedures and new global procedures, forms/templates and risk assessment for environmental monitoring and environmental controls.
* Remediation of local procedures, as required
* Implement roll out of new global procedures, forms/templates and risk assessment at local site.
* Completion of full risk assessment utilising new global template for the environmental monitoring process.
* Review of current environmental monitoring plans for compliance to ISO 14644 series, EN 17141, AAMI TIR52 and any other applicable standards, and update as required.
* Review of current process for annual cleanroom reclassification as per ISO 14644 and update as required.
* Completion of cleaning validations, as required.
* Deliver a completed cleanroom revalidation in compliance with global procedures and applicable standards.
* Lead the environmental monitoring program including but not limited to support investigations into EM warning limit and action limit failures, actioning and approving planned and unplanned significant cleanroom events, review and approval of requalification protocols and reports, providing input and knowledge into any ongoing projects which may have potential environmental impact, identifying opportunities for improvement within the current process.
Qualifications/Experience
Required Qualifications
* Minimum of 5 years experience in environmental monitoring in the medical device or pharmaceutical industry with strong working knowledge of applicable standards e.g. ISO 14644, EN 17141, AAMI TIR52, etc.
* Minimum of degree in Engineering or Life Sciences, degree in Microbiology preferable.
Preferred Knowledge and Skills
* Strong microbiological background
* Demonstrated ability in delivering tasks on time and to a high standard
* Expert in cGMP
* SME for environmental monitoring
* Experienced in cleanroom qualification
* Experienced in working within a quality management system
* Experienced in change control.
* Strong technical report writing skills.
* Experiences in statistical data analysis and data verification advantageous.