Sterilization engineer/ Senior Microbiologist

Job Title: Sterilization engineer/ Senior Microbiologist

Location: Grand Rapids, MI
Duration: 12+months (Possibility of extension)

POSITION DESCRIPTION:
Interfaces with diverse cross-functional team members to define and oversee environmental, sterilization and biocompatibility control policies to assure that Healthcare medical devices consistently comply with toxicological, microbiological and particulate contamination control requirements, standards, guidelines and industry practices, both domestic and international.

POSITION RESPONSIBILITIES:

· Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control.

· Serves as technical liaison with functional groups, manufacturing sites and sterilization sites.

· Evaluates materials and products and recommends appropriate biocompatibility assessment to meet requirements.

· Coordinates the biocompatibility testing of new products and materials.

· Ensure 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 and conducting regular training and assessments of all manufacturing sites.

· Administers the Environmental Monitoring Program for manufacturing areas, in order to provide the necessary information (e.g., viable and non-viable particulate counts, product bio-burden, water and surface microbial levels, etc.) to ensure an appropriately controlled environment meeting regulatory expectations and industry standards.

· 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.

· Reviews and approves plant cleaning and pest/vermin control practices.

· Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.

· Provides microbiological technical expertise to the Purchasing department in the selection and certification of component vendors.

· Defines handling and test requirements for microbiological contamination control of vendor-supplied components as well as work-in-process inventory.

· Assure timely, accurate and independent evaluation of product performance and compliance to sterilization and microbiology requirements prior to clinical studies or market release.

· Support other business units' sterilization sites and microbiology labs, and act as an expert and advisor to drive improvements and changes.

· Interface with validation teams and customers to determine sterilization needs.

· Provides statistical support by leading creation of sterilization related metrics for improvement purposes.

· Support Regulatory Affairs and other departments by providing reliability input in the evaluation of sterilization controls.

· Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing.

· Capable of working and leading cross functional team’s providing microbiological and sterilization expertise.

· Must have excellent knowledge of Microsoft word and excel. Statistical analysis a plus. Proficient report writing.

Basic Qualifications:

EDUCATION:

· Bachelor of Science degree in Microbiology or related technical discipline.

YEARS OF EXPERIENCE

· 5+ year’s industrial microbiology experience in the Medical Device or Pharmaceutical industry.

SPECIALIZED KNOWLEDGE 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), 14160 (Liquid), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN).

· Proven management and interpersonal skills.

· Excellent organizational and judgment skills.

· Ability to maintain and generate accurate records.