itContracting are seeking to recruit a Validation Engineer for our client based in Cork & Dublin
This is an 18 month contract
Key Responsibilities:
- Directly support the manufacturing operations in daily quality activities, investigations, and overall quality direction.
- Qualification and validation - Process & Cleaning Validation activities.
- Knowledge on Emerson Delta V DCS (Distribution control system) and report review.
- Knowledge on gQTS (Track wise) and electronic document management system.
- Responsible for control & verification of computer systems used in the management
- /execution and their privileges for all equipment’s related to manufacturing.
- Review of system generated Audit trial, Alarms, System privileges Reports, and Recipe printouts of manufacturing equipment systems.
- Coordinating with internal and external stakeholders to lead/deliver requirements for quality related elements like investigations, document approval, change control & CAPA in line with SOPs.
- Knowledge on Equipment installation and qualifications activities like DQ, FAT, SAT,
- IQ, OQ, PQ
- Knowledge on Regulatory & Customer Audits & internal audits.
- To work on Project configuration documents- Implementation plan, Site Base line configuration document (BCD), Master recipe configuration document (MRCD),
- Verification strategy (VSD) and verification completion documents (VCR).
- Trouble shooting EBR run time & Demonstration of control label printing, Barcodes, Scanners related service issues.
- Coordinating the recipe authors and guiding them with MES best Practices in the
- industry.
- Creation and Execution of Test plans, ensuring compliance with standards.
- Review and approval of Test Specification/Scripts, Requirements Specification, Requirements Traceability Matrix, Functional Specification, Design Specification.
- Review and approval of all testing for GxP related processes, activities and deliverables in controlled environment like IQ, OQ & PQ tests summary results and final validation reports.
- Review and approval of all issues/deviations, investigations and confirm mitigation for any open issues
Key Skills:
- Directly support the manufacturing operations in daily quality activities, investigations, and overall quality direction.
- Qualification and validation - Process & Cleaning Validation activities.
- Review of system generated Audit trial, Alarms, System privileges Reports, and Recipe printouts of manufacturing equipment systems.
- To participate in Process mapping, Recipe designing, Testing, Business verification, Dry Runs and implementation business works.
- Coordinating the recipe authors and guiding them with MES best Practices in the
- industry.
- Creation and Execution of Test plans, ensuring compliance with standards.
- Review and approval of Test Specification/Scripts, Requirements Specification, Requirements Traceability Matrix, Functional Specification, Design Specification.
- Review and approval of all testing for GxP related processes, activities and deliverables in controlled environment like IQ, OQ & PQ tests summary results and final validation reports.
- Review and approval of all issues/deviations, investigations and confirm mitigation for any open issues.
Experience required:
- Experience with Pharma customer working as Computer system Validation
- Experience in MES CSV Validation Processes, Rockwell Siemens
Candidates must be eligible to work in Ireland or currently hold a Stamp 1G/4 Visa to apply.
For more information, please apply here or contact Holly Grant (holly.grant@itcontracting.ie) in itContracting directly.
Eirevo / itContracting is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. Eirevo / itContracting apply all relevant Data Protection laws when processing your Personal Data.
If you choose to apply to this opportunity and share your CV or other personal information with Eirevo / itContracting, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at Eirevo / itContracting.
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