Job Description
Our client, a global healthcare leader, is currently recruiting for a Process Validation Engineer to join their growing team in Westport, Co.
Mayo.
6 Month Contract.
Responsibilities: As a Process Validation Engineer, you will: Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers.
Ensure that all validation requirements are met for any new process, equipment, or change to existing processes or equipment.
Actively work on validation projects, being the departmental point person, and complete all associated project documentation in line with current corporate and regulatory expectations.
Ensure that all documentation pertaining to each validation study under your responsibility is compiled, authorized, and filed in a timely and organized fashion.
Work with other validation engineers to achieve compliance by coordinating each validation project assigned.
This process involves the review and approval of validation documentation and coordination of the validation work.
Facilitate the PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process as per the current rota.
Keep abreast of current and changing regulatory guidance for the relevant areas of validation that apply.
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 company's stated quality objectives through continuous improvement efforts and conformance to quality standards.
Attend Departmental and APEX meetings and participate in any Quality and Safety Initiatives.
Qualifications: Bachelor's degree required in a 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 is beneficial.
Proficient in the 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: Email: emma.daly@collinsmcnicholas.ie Phone: 0861041202
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