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Remote Prin Microbiologist-Steriliz

Saint Paul, MN 55112

Posted: 09/12/2023 Employment Type: Contract Job Category: Scientific Job Number: 584857 Is job remote?: Yes Country: United States

Job Description


Max pay 65-80/h depending on experience

HM's Top 3:
1. 7+ years applied experience in contract ethylene oxide sterilization, specifically execution of validations and optimization of cycles (ISO 11135)
2. Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
3.Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently
Must Have
  • Education Required: Bachelor of Science degree in Microbiology or related technical discipline Years of Experience: 15+ years industrial microbiology experience in the Medical Device or Pharmaceutical industry
  • Specialized Knowledge or Skills Required: Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
  • Solid understanding of different types of sterilization methods (EtO, gamma, steam, etc.) including processes and equipment.
  • Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, E-Beam, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN). Specifically, Ethylene Oxide.
  • Excellent organizational and judgment skills. Ability to maintain and generate accurate records. Strong written, verbal communication skills.

Nice To Have
  • Certified microbiologist or Certified Industrial Sterilization Specialist. (Ethylene Oxide)
  •  Computer proficiency using word processors, spreadsheet, and project management.
  • Able to apply advanced scientific principles.
  • Good oral and written communication skills. Excellent presentation skills.
  • Must be able to handle multiple tasks/projects and manage business unit priorities accordingly.
  • Must be able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
  • Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
  • Working knowledge of statistical techniques

Education Required: Requires a University Degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Remote with possibility of travel

Position Description:

Principal Microbiologist-Sterilization Specialist Interfaces with diverse cross-functional team members to define and oversee environmental and sterilization control policies to assure that Medtronic medical devices consistently comply with microbiological and particulate contamination control requirements, standards, guidelines, and industry practices, both domestic and international.

 Responsibilities
  • Develop and executes sterilization validation protocols, manage work, document results in reports for contract ethylene oxide sterilization methods (ISO 11135): process definition, characterization, and validation.
  • Provides microbiological technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
  • Ensures compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices. Assures compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control, and conducting necessary microbiology related training.
  • Conducts OTR (Out of Tolerance Result) investigations, establishes actions to address OTR and reviews output of OTR Investigations with Quality Management.
  • Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers. Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
  • Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
  • Assures timely, accurate and independent evaluation of product compliance to sterilization, and microbiology requirements.
  • Supports Regulatory Affairs and other departments by providing technical input on sterilization, and microbiology related content of regulatory submissions and departmental procedures.
  • Willing to travel with minimum advanced notice.

 

Nice to Have
  • Degree in Microbiology, Chemistry, or similar field
  • Certified microbiologist or Certified Industrial Sterilization Specialist.
  • 10+ year’s industrial microbiology experience in the Medical Device or Pharmaceutical industry.
  • Working knowledge of statistical techniques
  • Knowledge of applicable ASTM, ISO, FDA and EN regulatory standards.
  • Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
  • Computer proficiency using word processors, spreadsheet, and project management.
  • Able to apply advanced scientific principles.
  • Good oral and written communication skills. Excellent presentation skills.
  • Must be able to handle multiple tasks/projects and manage business unit priorities accordingly.



Additional Duties from a sterilization/microbiologist 
  • Provides microbiological technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
  • Ensures compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices. Assures compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control, and conducting necessary microbiology related training.
  • Oversee Environmental Monitoring Program for manufacturing areas, in order to provide the necessary information (e.g., viable and non-viable particulate counts, product bioburden, water and surface microbial levels, etc.) to ensure an appropriately controlled environment meeting regulatory expectations and industry standards.
  • Conducts OTR (Out of Tolerance Result) investigations, establishes actions to address OTR and reviews output of OTR Investigations with Quality Management.
  • Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers. Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
  • Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
  • Provides microbiological technical expertise to the Supplier Quality department in the selection and use of component vendors. Provides input into the change control process for changes to supplier processes, materials and manufacturing environments which may impact sterilization, microbiology, and biocompatibility.
  • Assures timely, accurate and independent evaluation of product compliance to sterilization, and microbiology requirements.
  • Provides microbiological technical expertise in support of microbiology lab management. Provides feedback and recommendations to department manager on performance, goals, and status.
  • Supports other business units and microbiology labs, and act as an expert and advisor to drive improvements and changes, as needed.
  • Supports Regulatory Affairs and other departments by providing technical input on sterilization, and microbiology related content of regulatory submissions and departmental procedures.
  • Functions as part of the site Quality Engineering team and supports other Quality System elements (such as CAPA or Nonconforming Material Reports) as needed.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Paul, MN

Explore exciting job opportunities in the vibrant area around Saint Paul, Minnesota! Known as the 'Twin Cities' area along with Minneapolis, Saint Paul offers a dynamic job market with ample room for growth and development. Considered the state capital, Saint Paul boasts a unique blend of historic charm and modern amenities. From the iconic Cathedral of Saint Paul to the bustling Saint Paul Farmers Market, there is always something to discover in this culturally rich city. With renowned art galleries like the Minnesota Museum of American Art, world-class theaters such as the historic Fitzgerald Theater, and beloved sports teams like the Minnesota Wild hockey team calling the Xcel Energy Center home, there's no shortage of entertainment options. Embrace the Midwest's warm hospitality and endless outdoor activities in beautiful parks like Como Park and the Mississippi River trails. Let's kickstart your career in this thriving and enchanting region – browse our job listings today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.