Description:
Arcadis are seeking a CSV Engineer for rolling contract assignment on a hybrid basis for a pharmaceutical company in Dublin. This position has a high probability of extension upon completion of the primary 12 months
Position Summary
- The CSV Engineer will prepare the necessary documentation and monitor progress for technical projects across the organization.
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for GxP systems, including but not limited DCS (DeltaV), automated equipment, MES and associated local infrastructure.
- Providing input into the validation strategy for computerized systems, including leveraging approach.
- Ensuring adherence to relevant regulations and company procedures, including DI.
- Providing timely and pro-active CSV support and guidance to facilitate project timelines.
- Actively working with CSV colleagues within the project as well as the global CSV organization to ensure alignment with other projects.
- Escalating any potential compliance issues in a timely manner.
- Generate computer system validation documentation in accordance with company procedures and GMP guidelines.
Principal Responsibilities
- Act as Validation SME on computer systems onsite utilized to support GMP manufacturing, such as MES & DeltaV.
- Oversee and perform computer system validation activities.
- Ensures the approach and execution aligns to applicable regulations, GAMP 5, and Alexion procedures when introducing new computerized systems and equipment.
- Develop standard testing plans to ensure the integrity of all data produced by process equipment and computerized systems.
- Review of equipment specification/design/installation and validation documentation
- Provide validation support and process improvements to existing computerized systems and equipment.
- Give guidance on all activities related to computer and automation systems validation.
- Participate in Validation Risk Assessments to determine the level of testing required for new equipment.
- Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.
- Support sustaining and project Validation CSV activities across Bulk Drug Substance (BDS), Packaging and Laboratory areas.
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Validation documentation – drafting, reviewing and approving Validation documentation.
- Generation and resolution of protocol discrepancies and deviations that arise as required.
- Support investigations, resolve potential data integrity issues that occurred during validation studies and operations.
- Complete periodic reviews for computerized systems and investigate any potential gaps identified.
- Support regulatory and internal inspections for computerized systems.
- Be a champion for safe working practices and safety initiatives within the group.
- Planning and execution of all commissioning activities in adherence to site safety procedures.
Qualifications
- Minimum 5-7 years of experience in a relevant technical role or similar.
- In-depth understanding of the biopharma business, especially with regards to current quality and regulatory requirements.
- Experience of Testing GAMP Category 3, 4 & 5 systems.
- Experience at executing validation protocols, data management and data integrity.
- Subject matter expert for CSV Computer systems validation.
- In-depth knowledge of Annex 11 and 21 CFR Part 11 and GAMP requirements.
- Problem solver with a focus on achievement of overall project goals.
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.