The role
PE Global is currently recruiting for a Validation Engineer on behalf of a leading biopharma company based in Mayo. This is an initial 12-month contract role.
Overview
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 to 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.
Responsibilities
Over-see, coordinate, guide and implement the site validation master plan 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 rota’s.
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 company’s 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
Bachelor’s 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.
Expertise in the relevant subject matter areas – example Equipment Validation, Sterilisation Validation Facility Validations, Aseptic
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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