Principal Microbiologist

Principal Microbiologist

Role: Permanent

Division: Product Transfer

Who we want:

• Responsible for accelerating the pace and effectiveness of Product Transfer by developing a culture of innovation within the engineering team. Networks with key contacts outside own area of expertise while leveraging academic, industrial, GQO and divisional partnerships.    
• Technical leader from a Microbiological perspective oversight and leadership for Product Transfer team programmes and for setting technical direction and competency framework from a Microbiology perspective for the multi-site engineering team.  
• Work is performed without appreciable direction and may be self-initiated. Exercises considerable latitude in determining the technical objectives of the assignment. 

What you will do: 

• Will function in a technical leadership role from a microbiology perspective on Product Transfer programs. 

• Support Product transfer assessment activities to understand Microbiological / Sterilisation implications of proposed transfers.

• Develop microbiological / sterilisation test plans for product transfer projects.

• Co-ordination of generation, collection of samples for bioburden and endotoxin and other microbiological testing associated with product transfer projects. 

• Support setup activities associated with new Performing sampling for validations as required. Review of validation files for compliance. 

• Strong interactions, maintenance and support of sterility suppliers. . 

• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending. 

• Leads NC and CAPA generation and resolution within the Microbiology area for the Product transfer group.  Strong competency in troubleshooting, correction of NC and root cause analysis. 
• Collaborate cross-divisionally to understand all microbiological requirements and drive procedural best practice within Skawina site.  
• Ensure alignment across all programs from a microbiological perspective.

• Mentors and trains team and cross functional groups as required (induction, GMP etc) 

• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.

• Coach, mentor and train other functions in area of sterility and monitoring. 

• Review and approval of validation documentation. 
• Develops technical solutions to complex technical problems where analysis of situations or data requires an in-depth evaluation of variable factors. Solutions may require the regular use of ingenuity and creativity. 
• Assume the role of technical mentor for engineers in the function and supporting functions. 
• Will function in a technical leadership role from a microbiology perspective on major programs. 
• Develop a detailed understanding of "best practice" in product/process performance within the medical device industry. Will also benchmark against other divisions and industries with a view to driving best practices. 
• Develop a support network of key divisional/corporate leaders, academic and supplier partners to enhance understanding of product sterility requirement smanufacturing and quality. Networks with key contacts outside own area of expertise and across business units. 
• Lead a culture of innovation within the function by developing and implementing engineering forums and reviews for the engineering team. 
• Ensure adherence to GMP and safety procedures. 
• Review and approval of validation documentation. 
• All other duties as assigned.

What are we looking for: 

• Bachelor’s degree/ Master of Microbiology or equivalent 
• Minimum of 6 years in Quality/Regulatory Affairs environment or  6 years Microbiology related experience. 
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. 
• Experience in working in a compliance risk situation. 
• Broad based business experience in high performance multi-national enterprise, at least 3 years of which has been spent in operations and/or technical leadership level in Medical Device or other highly regulated industries. 
• Strong capability to network and influence at all organisation levels. Ability to build networks externally and leverage appropriately. 
• Both a logical and strategic thinker with the ability to identify and seize opportunities to advance the Stryker mandate. 
• Strong analytical ability with a high aptitude for understanding systems, gathering data and performing research. 
• Green or Black Belt 6 Sigma qualifications an advantage. 
• High level of PC Skills required. 
• Excellent attention to detail. 

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