Remote - Senior Microbiologist

About the role

Primary Talent Partners has a new contract opening for a Senior Microbiologist with our medical device client in Virtual, TN. This is a 10-month contract with a potential for extension.

Responsibilities

• Develop and execute sterilization validation protocols, manage work, document results in reports for contract ethylene oxide and radiation sterilization methods (ISO 11135 & ISO 11137): process definition, characterization, and validation.
• Ensure compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices.
• Assure compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control, and conducting necessary microbiology related training.
• Provide sterilization technical expertise during change control activities, process modification studies and failure investigations.
• Provide microbiological technical expertise during change control activities, process modification studies and failure investigations regarding microbiological contamination control.
• Serve as technical liaison with functional groups, contract laboratories and manufacturing sites.

Qualifications

• Minimum of a Bachelor's Degree is required, preferably a Bachelor of Science degree in Microbiology or related discipline.
• 7+ years relevant experience.

Preferred Qualifications

• Certified microbiologist or Certified Industrial Sterilization Specialist.
• Working knowledge of statistical techniques.
• Bachelor of Science degree in Microbiology or related technical discipline.
• 15+ years industrial microbiology experience in the Medical Device or Pharmaceutical industry.

Skills

• 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.

Pay

$45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.