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Validation Engineer

GENERAL SUMMARY:

Performs validation functions for the facility, including projects, strategy, scope, and resource requirements. Prepares protocols and reports for validation work. Coordinates validation activities by constant communication with affected departments and personnel. Oversees and reviews validation area process and procedures, to maintain regulatory compliance and verify advance to cGMP’s. Responsible for direction and supervision of Maintenance personnel, working closely with quality and regulatory to drive validation efforts throughout the company.
 

ESSENTIAL DUTIES:

 
·        Performs day to day validation functions, Validation of process, equipment and execution of product related initiatives.  Adhering to current regulatory and corporate requirements, to assure all plant wide validation initiatives meet corporate timelines.
·        Executes validation projects in the facility.
·        Coordinate validation activities with other departments to prevent interruption of production or testing activities.
·        Identifies equipment and systems that require validation
·        Writes Validation Protocols (IQ, OQ, PQ, and Process Validations) and routes for review and approval
·        Executes and/or coordinates the execution of the protocols
·        Reviews and writes Final Reports to complete the protocols
·        Responsible for change requests to maintain validation state of equipment
·        Monitor plant operations for cGMP compliance
·        Assists in the review and completion of requirements for new products
·        Recommend and follow-up Value and Process Improvement Projects (CIP)
·        Participates on the New Product team
·        Responsible for maintaining and scheduling the calibration of process equipment and laboratory equipment.  (Keeping track of re-validations and re-calibrations)
 
QUALIFICATIONS:
 
           Education and/or Experience:
 
·        B.S degree, or equivalent, in engineering or scientific discipline. 
·        2 years validation experience in an FDA-related pharmaceutical manufacturing environment with a proven track record of successful management of validation projects and their associated teams.
·        A thorough understanding of the validation requirements for compliance with cGMP, FDA, GDP, (CBER and CDER), ICH, and USP expectations; and an understanding of how these requirements are typically fulfilled by the pharmaceutical/biologic manufacturing industry.
·        Analytical, problem solving, and written communication skills.
·        Time management skills, and ability to work on multiple projects at once.
·        Technical/Scientific writing skills.
·        Critical thinking ability and able to analyze root cause problems and respond to critical situations
·        Interpersonal skills required for project team leadership and inter-company interaction with service organizations and regulatory agencies.
·        Results oriented, customer focused.
·        Familiarity with Statistical Analysis tools.
·        Design of Experiment (DOE)