Job Description :
Hi
I have an urgent position of Validation Engineer – Devens, MA. If you are available kindly send me your updated resume .

Role: Validation Engineer
Location: Devens, MA
Duration: 6+ months
M.O.I : Telephonic & Face to Face

Job Description: Executes validation efforts associated with the operation of GMP manufacturing systems including installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, qualification of environmental areas and qualification of critical process utility systems.

2. May perform multiple projects simultaneously. Technical work assignments and interfaces with project stakeholders.Maintains familiarity with site directives and industry guidelines on qualification/validation.
.Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent.
. Minimum of 5 years'' experience in biopharmaceutical industry is required.
Experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired.
. High attention to detail
. Familiarly with Piping and Instrumentation Diagrams for the purpose of system walkdowns
. Previous experience in one of the following areas process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping concepts is desired.
. Excellent project management, communication, and technical writing skills are required.
. Demonstrated effectiveness in both a team environment and an individual contributor role.
. Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
             

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