Sanaria is a rapidly growing, diverse, inclusive, multi-cultural, biotechnology company at the cutting edge of vaccine innovation. We are passionate about our goal to eradicate malaria. Sanaria employees are exceptional scientifically, mission-driven, and play a variety of roles in research, product development, manufacturing, clinical trials, and support of these endeavors. We celebrate our diversity and offer a strong benefits package including company paid life and disability insurance, health plans with employee and dependent subsidy, and 401k plan with company match.
The Validation Engineer will help to evaluate the equipment and procedures used in development and production of cGMP products. Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality cGMP products. Perform static and dynamic Environmental Monitoring and touch plate sampling. The Engineer may participate in manufacturing activities as time permits.
Essential Duties and Responsibilities:
Validation – Quality Assurance:
Primary duty is engineering and protocol testing/execution. Establish validation standards.
Develop testing protocols.
Prepare equipment for cGMP.
Document test results and maintain records for later analysis.
Coordinate with other personnel or departments who will be affected by testing.
Write deviations and change controls.
Write and execute standard operating procedures (SOPs)
The Validation Engineer may also perform environmental monitoring, assist with various QC tasks and QA reviews, and participate in vaccine manufacturing activities.
Minimum of a Bachelor’s degree, preferably in Biochemistry, Biology, Chemistry, or other scientific field and 2+ years of GMP documentation experience.
Knowledge of laboratory equipment and technology systems.
Knowledge of process and equipment validation techniques a plus.
Knowledge of equipment repair a plus.
Experience with EDMS. Experience with Novatek software a plus.
Familiarity with ICH and FDA guidelines, GMP regulations, and quality compliance requirements preferred.
Excellent writing skills and editing, formatting, and organization skills.
Excellent attention to detail and customer service attitude.
Please send cover letter, resume and required pay rate to careers(at)sanaria.com, subject line “Validation Engineer.” For more information, please visit www(dot)sanaria.com.
Job Type : Full-Time
Education Level : Bachelors Degree, Masters
Experience Level : Entry Level, Mid to Senior Level