Job Description
The role: PE Global is currently recruiting for a Validation Engineer on behalf of a leading biologics company based in Mayo. This is an initial 6 month contract role. Purpose: The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the Westport manufacturing site. The Department is also responsible for the revalidation of critical systems & processes. The role of the Validation Engineer is the ensure customer satisfaction is delivered with each revalidation, validation and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BUs and ensuring all projects can be managed and prioritized as required. Responsibilities: Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment. To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations. To ensure that all documentation pertaining to each validation study under his / her responsibility is compiled, authorized and filed in a timely and organized fashion. To work with the other validation engineers to achieve compliance by coordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work Participate in risk assessment process for all business units & participate in design review process for all business units. Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.) To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rotas. Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit response. Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department. Achieve the companies stated quality objective through continuous improvement efforts and conformance to quality standards. Attend department and APEX meetings and participation in Quality and Safety initiatives. Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review). Education and Experience: Bachelors degree required in science based or engineering discipline Experience in Pharmaceutical company Excellent project management skills Proficient in use of Microsoft Office suite of programs Critical thinking and problem-solving skills Ability to articulate clearly when dealing with internal and external bodies. Excellent conflict handling skills Expertise in the relevant subject matter areas example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: validation aseptic project management