Job Description :
Project Validation Engineer

Location: Devens, MA

Duration: 6+ months, likely extended further

Interview: Phone then in-person

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.

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.
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.
Familiarly with Piping and Instrumentation Diagrams for the
purpose of system walk downs
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.
             

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