Key Facts

Remote From:

Minnesota (USA)

Category: Microbiologist

Full time

Mid-level (2-5 years)

English

Hard Skills

Microbiology Aseptic Processing Environmental Contamination Sterilization Validation Environmental Monitoring Microbiological Testing Cleanrooms Technical Writing

Other Skills

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Analytical Skills
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Detail Oriented
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Communication
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Collaboration
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Time Management

Roles & Responsibilities

Bachelor's degree in Microbiology, Biology, or related scientific discipline required
Minimum 4 years of relevant experience in microbiology, sterility assurance, contamination control, or aseptic processing in a regulated GMP environment
Strong hands-on microbiology expertise required
Strong working knowledge of ISO 13485, ISO 13408, ISO 14644, FDA Aseptic Processing Guidance, EU GMP Annex 1

Requirements:

Serve as a site SME for microbiology, sterility assurance, aseptic processing, and contamination control
Implement and continuously improve the site Contamination Control Strategy (CCS)
Oversee the site environmental monitoring program, including trending, response procedures, and investigation triggers
Train and mentor staff on microbiological techniques, aseptic behavior, contamination control, and cleanroom practices

Evergen

About Evergen

Evergen is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neurosurgery. Our Mission is to enhance patients' lives by creating the best clinical outcomes through innovative, high-quality medical solutions.

Founded: 2018

Company size: 501 - 1000

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Job description

Location: Eden Prairie, MN

Annual CIP bonus opportunity of up to $5,000.00

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM 

RESPONSIBILITIES

Serve as a site SME for microbiology, sterility assurance, aseptic processing, and contamination control.
Implement and continuously improve the site Contamination Control Strategy (CCS).
Oversee the site environmental monitoring program, including trending, response procedures, and investigation triggers.
Support microbiological testing and method qualification including bioburden, endotoxin, sterility, and microbial characterization.
Review batch records, interpret microbiological data, trends, and other quality documentation to assess compliance and product impact.
Lead or support investigations involving microbiological OOS/OOT results, EM excursions, contamination events, and sterility failures.
Provide microbiology support for aseptic processing, gowning qualification, sanitization/disinfection, clean utilities, validation, and qualification activities.
Train and mentor staff on microbiological techniques, aseptic behavior, contamination control, and cleanroom practices. Maintain a visible floor presence to support operations, coaching, and issue resolution.
Author, review, and approve SOPs, protocols, reports, risk assessments, and related GMP documentation.

Qualifications

Education

Bachelor’s degree in Microbiology, Biology, or related scientific discipline required. (Master’s degree preferred)

Experience

Minimum 4 years of relevant experience in microbiology, sterility assurance, contamination control, or aseptic processing in a regulated GMP environment.
Strong hands-on microbiology expertise required, including direct experience with microbiological testing methods and laboratory practices, and environmental monitoring methods.
Experience with cleanroom operations for aseptic manufacturing in a regulated environment.
Strong working knowledge of ISO 13485, ISO 13408, ISO 14644, FDA Aseptic Processing Guidance, EU GMP Annex 1.
Experience with collagen-based product manufacturing in pharmaceutical, biopharmaceutical, biotechnology, or medical device industries.
Strong knowledge of sterilization methods such as ethylene oxide (ISO 11135), gamma irradiation (ISO 11131), filtration (ISO 13408-2), and liquid chemical sterilant (ISO 14160) modalities.

Skills

Strong attention to detail and documentation practices.
Strong hands-on knowledge of bioburden, sterility, endotoxin, microbial identification, and environmental monitoring.
Understanding of cleanroom classifications, aseptic gowning, contamination control, and EM systems.
Familiarity with sterilization methods and validation principles, including filtration, EO, gamma irradiation, and related approaches as applicable.
Strong analytical, investigation, root cause analysis, and technical writing skills.
Ability to work independently, manage multiple priorities, and make sound risk-based decisions.
Strong communication and cross-functional collaboration skills.

Travel

Safety:

Physical Requirement

Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions

More about Evergen:

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

Accountable: We own our actions and decisions.
Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
Growth Mindset: We embrace challenges as opportunities for continuous learning.
Customer-Centric: We prioritize customers at every touch point.
Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.

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