Lab Validation Engineer
2 weeks ago
LABORATORY VALIDATION ENGINEER
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. This schedule compliance will be achieved by actively engaging with senior management and the impacted BU's and ensuring all projects can be managed and prioritized as required. This is a 6 month contract 100%based onsite in co Mayo.
Responsibilities:
- Over-see, coordinate, guide and implement the site validation master. 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, completing all associated project documentation in line with current corporate and regulatory expectations. To work with the other validation engineers to achieve compliance by coordinating each validation project assigned.
- 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.
- Provide support for audit preparation, direct audit interaction and involvement in audit response.
- Support and comply with internal EHS requirements, procedures and policies. 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).
Qualifications:
- 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
- Excellent conflict handling skills
- Expertise in the relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning
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