Job Title: Validation Specialist
Reports To: Engineering Manager
Author, execute, and summarize validation protocols. Coordinate and manage validation project execution for equipment, critical utility, process, cleaning, and computer related systems. Ensure protocols, records, and procedures are in compliance with regulations and current Good Manufacturing Practices (cGMP).
- Coordinate and execute validation studies (IQ, OQ, PQ etc): writing protocols, analyzing and documenting results, and generate final summary reports. Validation activities include but not limited to equipment/system qualification, packaging process validation, cleaning/ sanitization validation, and computer related systems validatio
- Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
- Coordinate validation activities with plant support groups (Operations, Maintenance, Technical Services, Quality, etc.) for timely protocol execution
- Work with cross functional teams during the entire process life cycle and provide technical assistance and training as a subject matter expert.
- Assist in identifying, analyzing, and correcting manufacturing issues for process optimizatio
- As needed, conduct Process Capability studies for the manufacturing processes using Six Sigma and other applicable SPC methodology and recommend process improvements.
- Follow and recommend improvements as applicable in policies and procedures to management and maintain compliance with site, corporate and regulatory standards
- B.S. in a Life Science or Engineering,Recent grads are welcome to apply!
- Excellent writing skill
- Detail Oriented
- Knowledge of the following a plus;
- FDA regulations, cGMP
- Six sigma and SPC methodology
Chembio Diagnostic Systems, Inc. is a public company serving the increasing global demand for rapid tests needed for the effective prevention and treatment of infectious diseases and other conditions.
Located minutes off the Long Island Expressway in Medford, NY, Chembio operates a research and manufacturing facility that is registered with the US FDA.
We offer a pleasant working environment, competitive salary based upon experience, and an excellent benefit package. For immediate consideration, please send resume and salary requirements to firstname.lastname@example.org For more information about Chembio Diagnostic Systems Inc., please visit our website at www.chembio.com
Chembio is an Equal Opportunity Employer.