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Prin Microbiologist-Steriliz

Employer
ATR International
Location
Burnsville, Minnesota, US
Salary
Competitive
Closing date
Sep 28, 2023

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Project Management
Salary Type
Salary
Employment Type
Full time
We are seeking a Prin Microbiologist-Steriliz for a very important client.

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 Company 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.
#Pando

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.
Requirement:
The ideal candidate will possess the following qualifications:

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

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

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

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.

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience May have broad knowledge of project management Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
PandoLogic. Keywords: Surgical Technician, Location: Burnsville, MN - 55306PDN-9a348af7-d146-481a-b527-0b7cc7946043

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