LSC have a great contract opportunity for a C&Q Engineer to join an innovative and rapidly growing Biopharmaceutical company in Limerick.
If you have experience in C&Q activities with Large Equipment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - EXPECTED DELIVERABLES:
- Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
- Generates, executes, reviews qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Analyses the results of testing and determines the acceptability of results against pre- determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Co-ordination with cross function for: interdependent tasks, decision making, timely escalations on quality events/project delays, safety etc.,
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Capability to work as independent contributor as well as team tasks.
- Well versed with safety practices at site.
- Trains/advises less experienced specialists and technicians.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation per site SOPs.
- Manages projects and prepares status reports.
- Familiarity with equipment in QC, manufacturing (drug substance-Especially MAbs), AHU, Facilities, utilities
- Basic familiarity with paperless validation tool like ValGenesis
- Working to expert level knowledge in 21CFR part 11, Computerized system, PLC/HMI/SCADA systems, Audit trail etc.,
- Familiarity with deliverables minimum but not limited to:
- URS
- DQ, lQ, OQ, IOQ
- Commissioning Protocol
- Traceability Matrix
- Summary Reports
- Turn Over Package
- SOP
- 21 CFR part 11 assessment
- Data integrity assessments
- Protocol change controls/Deviations etc.,
- System Life cycle documents.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 8-10+ years of related experience within the field; will substitute relevant experience for education.
- Qualification/validation experience required.
- Well versed with Microsoft tools like: Word, .xls, .ppt etc.,
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Paul O'Driscoll at LSC on 021-4777329 if you have any more questions about this opportunity.
