Our client, a global healthcare leader is currently recruiting for Process Validation Engineer to join their growing team in Westport, Co. Mayo. 6 Month Contract
Responsibilities:
As a Process validationEngineer, you will:
Key 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 processes 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, authorised and filed in a timely and organised fashion. To work with the other validation engineers to achieve compliance by co-ordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work
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 guidances 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 EHS within the department. Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards. Attend Departmental and APEX meetings and participation in any Quality and Safety Initiatives.
Qualifications:
Bachelor’s degree required in science based or engineering discipline
2 years’ experience in a Pharmaceutical company or similarly regulated manufacturing environment.
Excellent project management skills in Process Validation
Experience in Equipment/Cleaning Validation beneficial
Proficient in use of Microsoft Office suite of programs and skills in documentation.
Critical Thinking and Problem-solving skills
For a confidential discussion and more information on the role, please contact Emma Daly
emma.daly@collinsmcnicholas.ie
0861041202