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Job Description
Process validation engineer required to oversee site validation master plan, ensure validation requirements are met, and work on validation projects.
Our client, a global healthcare leader, is recruiting for a Process Validation Engineer to join their team in Westport, Co. Mayo. This is a 6-month contract position.
Key Responsibilities:
- 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 his/her responsibility is compiled, authorised and filed in a timely and organised fashion.
- Work with other validation engineers to achieve compliance by coordinating each validation project assigned.
- Review and approve validation documentation and coordinate the validation work.
- Facilitate the PQR review process and regulatory review process and laboratory equipment review process.
- 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 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 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.