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Validation Engineer II
Ref No.: 17-21394
Location: Rocky Mount, North Carolina
Immediate need for a Senior Validation Engineer  with experience in the Pharma  Industry. This is a 12 months contract opportunity with long-term potential located in Rocky Mount,NC. Please review the job description below:


Job ID:17-21394


 Key Responsibilities/
 Key Requirements and Technology Experience:


 
  • The Associate Validation Engineer will be responsible for writing and executing validation protocols for equipment/computer system qualifications.
  • The engineer will complete validation activities in compliance with Quality System requirements and recognized international standards.
  • An emphasis will be placed on risk management and root cause analysis.
  •  Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
  • Ensure all aspects of validation adhere to required policies and procedures, including safety and training.
  • Writing and execution/coordination of validation protocol testing.
  • Compile and report on relevant validation data and generate summary reports to document the results of the validation studies.
  • Aides in troubleshooting/impact assessment for atypical conditions during validation runs/validations.
  •  Assist in the development of any existing validation program to ensure continued compliance to thenecessary regulations.
  • Will have interactions with Manufacturing, Quality, Engineering, Automation and Validation Personnel at both entry and senior level positions.
  • The candidate would need good people skills and get along well with others in a team environment.
  •  Degree in a technical discipline, or relevant experience and education
  •  Minimum of 2 years manufacturing/technical experience in a pharmaceutical or regulated GMP environment
  •  Strong computer system, software and/or equipment validation experience
  • Indicate the technical skills required and/or preferred, as applicable.
  • Possess strong project management, organizational, analytical, computer, writing and communication skills.
  • Knowledge of manufacturing computer systems, PLCs, manufacturing equipment, aseptic processing, terminal sterilization is highly desired.
  • Knowledge of cGMP regulations and latest validation guidelines essential.
  • Must be able to handle multiple priorities in a fast-paced environment. Able to work extended/odd hours around manufacturing schedule as required.
  • Note the physical conditions in which work will be performed, if applicable to the position.
  • Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.
  • Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance.
  •  Possible lifting < 25 lbs. Candidate must be able to lift and carry light loads as necessary with conducting testing.
  •  Possible weekend, early morning, and late night work
  • Possible long hours based on testing schedule
  • Must wear proper gowning and PPE in manufacturing areas as required to meet GMP and OSHA requirements


Our client is a leading Pharma Industry and we are currently interviewing to fill this and other similar contract positions. Qualified candidates should apply online for immediate consideration.