Description
New Build Greenfield Biotech facility based in Dublin have an URGENT contract requirement for an experienced QA Validation Engineer to work on this exciting state-of-the-art project.As QA Validation Engineer you will be responsible for providing quality support for the qualification of manufacturing equipment and utilities ensuring the equipment/facility/utility validation documentation is in compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations, ICH and PIC Guidelines.
Role and Responsibilities:
- Quality review and approval of equipment and utility qualification Documentation including Design documents, Process and Instrumentation Drawings, FAT/SAT/IQ/OQ/PQ protocols and reports and Validation Masterplans.
- Provision of Real Time Quality Support during the execution of qualification/validation activities from SAT to PQ including making decisions on quality issues.
- Provision of QA support for Mechanical Completion (MC) Walkdowns.
- Ensure equipment/utility changes are implemented promptly and compliantly as per change control procedures.
- Participation in Facilitated Reviews with multi-disciplined teams, review and approval of Quality Risk Assessments (QRA).
- Project co-ordination & communication of issues to team members & management.
- Degree in Engineering/Science Discipline.
- Proven background in the Quality review and approval of qualification/validation documentation within a pharmaceutical/biopharmaceutical manufacturing organisation.
- Experience in Manufacturing Equipment and Utility Qualification essential.
- Experience in Biopharmaceutical Manufacturing Equipment including Bioreactors, Centrifuges, Chromatography Purification columns and Filtration systems is highly desirable.
- Knowledge of ASTM E2500 risk approach to verification, desirable.
- Good working knowledge of EMA/FDA Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
- Ability to participate in cross functional teams in addition to working on own initiative.
- Some weekend work OR shift Saturday to Wednesday may be required.