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DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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Prawin at
Location: Onsite/Hybrid in Round Lake, IL, 3 days onsite and 2 days remote
Work Schedule: 8-hour workdays (between 7-5)
1. Basic technical understanding of sterilization (Moist Heat, Aseptic, Irradiation)
2. Basic technical understanding of microbiological method validations (sterility, bioburden and bacterial endotoxin) (specific for the Research Associate II)
3. Ability to write, execute and review validation and qualification protocols and reports.
4. Ability to evaluate and interpret technical data and test results
2-4 years of recent experience preferred
1. Understanding of aseptic technique (RAII)
2. Ability to conduct experiments with minimal assistance
3. Knowledge and understanding of GxP and related regulations and guidance
- Effectively contribute solid technical knowledge to a variety of projects within the sterility assurance discipline with minimal assistance.
- Display basic technical understanding of related sterility assurance disciplines, specifically sterilization modalities and/or microbiological test method validation.
- Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
- Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines.
- Maintain knowledge of relevant Quality System Regulations and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
- Recommend appropriate designs, techniques and processes for a specified sequence of tasks where needed.
- In-depth knowledge and understanding of GxP and related regulations and guidance.
- Provide support to the Sterility Assurance Focal Point for product development or on change controls.
- Write, execute and review validation and qualification protocols and reports.
- Evaluate and interpret technical data and test results.
- The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
- Bachelor's Degree in a scientific discipline with at least 2-4 years lab experience.
- Background in microbiology
- somebody that knows the basics of microbiology, aseptic technique has worked with organisms in a lab.
- Ideally would be somebody that has a sterile assurance.
- Understanding a little bit of the micro methods and validations required for a pharmaceutical company.
- it's a research associate 2 level, so has a few years of experience in the lab.
- And also looking for them to help with report generation. So analyzing data and putting it into a template for report.
- word, excel basic general understanding of the Microsoft platform would be enough.
- work will be report generation and data analysis, probably 80% 20%.
- Bachelors degree 2 years will be ideal
- Looking for biology or microbiology, but any really of those extensions, if they have lab skills or have done plating and dilution working with microorganisms.
- Masters, if they have maybe one year of experience would probably be OK, but PHD may be overqualified for this level.
- Academic lab experience be considerable
Interview process: 2 interviews (Teams and Onsite, Length, Rounds, Team involved) Teams, one round, two team members involved, 30-45 minutes.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.