Biotechnology Quality Engineer

7 days ago


Arthur, Illinois, United States Lynkx Staffing LLC Full time
About the Position
We are seeking a highly skilled Biotechnology Quality Engineer to support two local sites serving as a support role to clinical and/or commercial production. The estimated salary for this position is $70,000 - $100,000 per year. As a Biotechnology Quality Engineer, you will coordinate data for batch release, participate in project/client meetings, author/revising microbiological testing procedures, perform microbiological testing including growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin, ensure equipment is in proper working conditions, maintain/calibrate all equipment, ship test samples and equipment to contract laboratories for testing, and complete all documentation according to written Standard Operating Procedures in accordance with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

About the Team
Lynkx Staffing LLC has a team of experienced professionals who are dedicated to providing exceptional service to our clients and candidates. We are committed to excellence and strive to create a positive and supportive work environment. You will have the opportunity to work with a diverse group of individuals and contribute to the success of our organization.

Responsibilities
As a Biotechnology Quality Engineer, your responsibilities will include:
* Coordinating data for batch release
* Participating in project/client meetings
* Authoring/revising microbiological testing procedures
* Performing microbiological testing including growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin
* Ensuring equipment is in proper working conditions
* Maintaining/calibrating all equipment
* Shipping test samples and equipment to contract laboratories for testing
* Completing all documentation according to written Standard Operating Procedures in accordance with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Requirements
To be successful in this role, you will need a BA/BS in a science or relevant field required or equivalent experience, 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, training in GxP/GDP Training, Safety Training, proficiency with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, strong written and oral communication skills, and technical writing skills.

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