CSV - Engineer

CSV Engineer – DublinAbout the Job

Oleson specialises in delivering high-quality talent and solutions that enhance the capabilities and operational excellence of our global customers.

We are focused on matching the dynamic needs of Data Centre and Life Science clients with skilled professionals, thereby driving innovations and in growth in these critical sectors.

Role Description:

The CSV Engineer will prepare the necessary documentation and monitor progress for technical projects across the organization. They will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the bio pharma industry. Act as Validation SME on computer systems onsite utilized to support GMP manufacturing, such as MES & DeltaV. Oversee and perform computer system validation activities.

What you’ll do:

• Ensures the approach and execution aligns to applicable regulations, GAMP 5, and company 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 the site.
• 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.
• Planning and execution of all commissioning activities in adherence to site safety procedures.
• 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.
• Providing timely and pro-active CSV support and guidance to facilitate project timelines.
• Generate computer system validation documentation in accordance with company procedures and GMP guidelines.

The Requirements:

• Degree in Engineering/Life Sciences/Computer Science.
• Minimum 5-7 years of experience in a similar role.
• 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.
• SME for CSV Computer systems validation.
• In-depth knowledge of Annex 11 and 21 CFR Part 11 and GAMP requirements.
• Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
• You must be legally entitled to work in Ireland as sponsorship is not provided for this role.