Job Description
A Validation Engineer is required for a 12-month contracting position at a Waterford-based Pharmaceutical client. The ideal candidate will have experience in Validation in an API environment.
Role of this Position
* Integrally involved in the validation of all new equipment, processes, and control systems.
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, laboratory equipment, and computerized systems.
* Participates in the change control process, advising on validation issues as necessary.
* Hands-on role in the development and execution of DQ, IQ, OQ, and PQ activities.
* Ensures projects are managed in compliance with all required legal requirements (Health & Safety, cGMP, construction, environmental, etc.).
* Designs, implements, and executes validation studies for manufacturing and control equipment, including critical systems and facilities, and validation studies to satisfy regulatory compliance.
* Provides technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing, and sterilization.
* Ensures that the validation status of equipment and systems is in compliance with cGMP at all times.
Job Requirements
* Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
* 3-5 years of experience working in a Healthcare manufacturing environment, ideally in the pharmaceutical sector.
* 2-3 years of experience in a validation environment.
* Experience in qualifying laboratory equipment.
* Knowledge of GAMP, ISPE Baseline Guide requirements is desirable.
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines is desirable.