Validation Engineer

Job Title:

Validation Engineer

Department:

Manufacturing Engineering

Reports To:

Senior Engineering Manager

Position Summary:

Design/ develop/ improve/ source manufacturing processes, equipment/ tools, and systems. Evaluate process and product design for manufacturability and suggest improvements for quality, cost reduction, and efficiency. 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 21 CFR 11, 210, 211, & 820 and current Good Manufacturing Practices (cGMP).

Responsibilities include but are not limited to:
  • Participate in NPI activities by evaluating the product design for manufacturability and manufacturing process for improvement opportunities. Participate in scale-up activities and product and process validation activities.
  • Coordinate and execute validation studies (IQ, OQ, PQ FAT 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 validation.
  • 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 executions.
  • 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 optimization.
  • Assess current manufacturing processes, equipment, tooling to identify and execute improvement opportunities.
  • Conduct Process Capability studies for the manufacturing processes using Six Sigma and other applicable SPC methodology and recommend process improvements.
  • Assist in the development, design, and validation of new manufacturing processes, including tooling design and fabrication.
  • Follow and recommend improvements as applicable in policies and procedures to management and maintain compliance with site, corporate and regulatory standards.
  • Ability to handle multiple tasks, projects or assignments.
Requirements:
  • B.S. in Mechanical Engineering or Industrial Engineering;
  • 2-5 years of relevant experience in pharmaceutical, biotech or medical device industry;
  • Working knowledge of cGMP, GLP, QS, FDA regulations;
  • Experience with development of master plans, IQ, OQ PQ, SOPs;
  • Proficient in the use of SolidWorks / AutoCAD;
  • Experience using machine shop tools are desirable;
  • Experience with the following a plus:
    • Six sigma and SPC methodology experience;
    • Ability to review P&ID, FATS, SATS etc.
Company profile

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 including a 401(k) with company match. For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

For more information about Chembio Diagnostic Systems Inc., please visit our website at www.chembio.com