Principal Microbiologist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Remote or Hybrid or Onsite
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:
- Bachelors degree/ Master of Microbiology or equivalent
- Minimum of 6 years in Quality/Regulatory Affairs environment or6 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.
#IJ
Travel Percentage: 30%Required Experience:
Staff IC
Key Skills
- Laboratory Experience
- Aseptic Technique
- Virology
- Clinical Laboratory Experience
- FDA Regulations
- Laboratory Procedures
- PCR
- Microbiology
- Quality Control
- GLP
- cGMP
- Laboratory Information Management Systems
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
