Job Description
The Validation Engineer / Specialist will be responsible for supporting Validation activities including qualification and requalification of new and existing systems, equipment, utilities and facilities. This role will liaise with key departments and with third party suppliers, contract and vendor personnel as necessary to deliver the required objectives and in accordance with the overall Validation Master-Plan and Schedule. Duties: * Responsible for planning, executing, reviewing & reporting validation activities supporting the qualification and requalification programs, Qualification will include Capex projects across a range of production areas including Cleanrooms, Facilities, Utilities, Production and Packaging equipment for a sterile manufacturing facility. * Participate in project teams to assist in determining project schedules and be able to make risk-based decisions regarding the appropriate level of validation. * Support in providing technical and compliance inputs to Validation and supporting documents ensuring compliance to cGMP. * Responsible for input into the generation and documenting of process risk assessment / failure mode and effects analysis as required relating to introduction of new equipment supporting the Validation effort. * Responsible for tracking and resolving exceptions during qualification activities. * Represent validation at internal and external audit as requested. Requirements/Experiences: * Minimum of a Degree in a Science, Engineering or technical related discipline and 2+ years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment is preferable but not essential. A combination of experience and/or education will be taken into consideration. * Experience and in-depth of Validation Processes, Equipment, Facilities and Utilities qualification will be a distinct advantage. * Must possess knowledge of pharmaceutical and medical device regulatory requirements for FDA and HPRA regulated environments. * Must possess knowledge of Pharmaceutical Manufacturing Programs * In depth knowledge of steam sterilization processes, cleanroom qualification, process gases qualification and packaging equipment qualification is desirable. * Must possess strong project management and organizational skills. Self-motivation and drive. * Excellent interpersonal, communication (written & oral) & technical report writing skills. * Must be flexible and able to manage multiple priorities simultaneously. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on (phone number removed)