A Validation Engineer is required by CareerWise Recruitment for our Mayo based pharmaceutical client. This is a 12-month contract position. This is a hybrid position with 3 days required on site. If you have experience in Process Validation then this is the position for you !!!
THE ROLE:
- 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.
- 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
- Facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota’s.
- 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).
REQUIREMENTS:
- 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.
- Ability to articulate clearly when dealing with internal and external bodies.
- Excellent conflict handling skills.
- Expertise in the relevant subject matter areas – example Equipment Validation, Sterilisation Validation Facility Validations, Aseptic
Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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