Our client a leader in the Pharmaceutical Industry is seeking a Laboratory Validation Engineer to join their team in their Westport facility on an 6 month contract initially.
LABORATORY VALIDATION ENGINEER
Purpose:
The QC Pharma Department is responsible for the qualification / validation of laboratory equipment, systems and processes utilized for routine operation at the AbbVie Westport Laboratories. The Department is also responsible for the revalidation of critical systems.
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.
Responsibilities:
1. Over-see, coordinate, guide and implement the site validation master 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.
2. 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, 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
3. Participate in risk assessment process for all business units & participate in design review process for all business units.
4. Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire
5. To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota's.
6. Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit response.
7. 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.
8. 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:
9. Bachelor's degree required in science based or engineering discipline
10. Experience in Pharmaceutical company
11. Excellent project management skills
12. Proficient in use of Microsoft Office suite of programs
13. Critical thinking and problem-solving skills
14. Ability to articulate clearly when dealing with internal and external bodies.
15. Excellent conflict handling skills
16. Expertise in the relevant subject matter areas – example Equipment, Facility, aseptics, Process, CPV, CSV, Cleaning