The CSV Engineer, reporting to the Quality Manager, will be involved in ensuring that the installation and qualification of Quality Management System (QMS) computer software onsite is complete in accordance with cGMPs, GAMP, 21 CFR Part 11 and other applicable regulations. This position will assist in liasing with the vendor, preparing/reviewing documentation and will engage in activities to support commissioning, validation, and qualification as required.
- Coordination / direction and active participation in the validation of site computer systems and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Generation of validation plans, protocols and final reports to cGMP standard; execution of validation testing is not required
- Review / approval of all protocols and final reports.
- Management of validation change control process
- Adheres to and supports all EHS & E standards, procedures and policies.
- Adheres to company training plan.
- Perform Periodic Validation Reviews of existing validated systems
- Perform validation transfers of centrally validated global IT systems
- Initial qualification (as per ASTM E2500) and change management of all elements of SAP, MES, DCS (Delta V) and PLC systems e.g. phases, recipes.
- Initial qualification and change management of QC Laboratory related computer systems e.g. Empower, HPLC etc
- Familiarity with the current industry data integrity requirements.
- May be required to travel and participate in FAT’s
The Ideal Candidate
Ownership and Accountability
- Position has a high level of autonomy and individuals are expected to work on their own initiative
- Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and IMB/FDA regulations and company policies, procedures and guidelines
- Individual is fully responsible for the co-ordination and closure of projects assigned.
- Position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
- Position impacts on product quality and technical performance as well as manufacturing operations
- Requires an ethos of Right First Time at all times
- Excess of normal hours may be required depending on business needs
- Close contact with employees within the plant at all levels
- May have close contact with internal and external auditors, e.g. FDA, IMB.
- May lead and chair cross functional team meetings
- Provide technical leadership to functional areas and collaborates with key stakeholders
- Expected to provide functional expertise to support daily operations.
- Seeks manager's input when making decisions which effect the area
- Is a site SME on Computer System validation issues and provides guidance on same
- Decision making within confines of agreed responsibility with Team Leader
- Individual is given authority to carry out their duties without close supervision
- Reports to Validation Team Leader within the Quality Assurance function
- Performance will be reviewed continuously with employee and feedback will be provided to GXP Systems.
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About the Company
Stericycle GxP Workforce provide the best engineering experts in their field; experts who like the variety and challenges of working in new and innovative environments; who get the job done and have pride in their achievements.
Located in Cork, Ireland and with customers across global sites, we can offer our Engineers a great place to work with excellent working conditions. Our customers are responsible for some of the most significant medtech & pharmaceutical products of our time, so the projects that our people work on can directly affect patients and improve their quality of life.