Microbiology/Sterilization Engineer

Experience Level Required : 5-7 years of relevant experience

Job Description :

1. Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies supporting medical devices
2. Perform standard sterilization engineering assignments for application, validity, and conformance to specifications
3. Analysis and evaluation of sterilization studies data and assist in preparing documentation using Good Documentation Practices (GDP)
4. Support with coordination and development activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation)
5. Ensure compliance with quality system and sterilization standards requirements ISO 13485, ISO 11135, and ISO 11137; DMR and ECN per 21CFR 820, ISO 14971
6. Lead and ensure validation actions comply with all international sterilization standards and meet all regulatory compliance requirements for sterile products
7. Work with cross-functional teams to develop, test, validate, and commercialize package solutions / Medical devices for new and existing products
8. Developing, reviewing, and approving the packaging documents: packaging component specifications, packaging component drawings, design history files, and risk/criticality assessments.
9. Sealing process characterization study based on ISO 11607
10. Lead Microbiology lab for Test method validation for Pyrogen Testing as per USP Standards
11. Strong operations professional skilled in Validation, Packaging, Sterilization, and Cleanroom Operations. Knowledge in DMR, DHR, PFMEA, CAPA, and FDA inspection
12. Coordinate and manage testing activities with contract laboratories

Education : . Master’s degree in a scientific discipline (Microbiology/Bio-Technology/ Science/ Pharmacy) with relevant experience in sterilization validation or equivalent

Required Skillset(s):

. The candidate should have knowledge of microbiology and sterilization techniques for medical devices (EO and Radiation gamma preferably), also general Quality Management System knowledge
. Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods
. ISO 13485 experience preferred Knowledge, Skills, & Abilities
. Technical writing skills, remote support for projects, strong interpersonal skills, and with a quick adaptive mindset for new technologies.
. Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (11607, ASTM, ISTA)
. Strong problem-solving skills across a broad range of complexities.

Job Type: Full-time

Pay: $90,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Brooklyn Park, MN 55445: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Sterilization Validation / Microbiology methods validation: 7 years (Required)
• ISO 13485: 1 year (Preferred)
• Packaging Design and Testing: 1 year (Required)

Work Location: In person