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Direct message the job poster from Cognizant Life Sciences Manufacturing.
Cognizant is a world leader in delivering digital transformation solutions to Life Sciences.
Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.
Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and Io T applications, infrastructures and services.
Operating across 5 continents and with over 300,000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market.
We are your single end‑to‑end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We're looking for dedicated, innovative and driven talent to join our expanding team.
We are looking to add an experienced CSV Engineer to the team of our pharmaceutical client based in Dublin.
Role Summary
The CSV Engineer will prepare the necessary documentation and monitor progress for technical projects across the organization.
The incumbent 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.
Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for Gx P systems, including but not limited to DCS (Delta V), 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.
Responsibilities
Act as Validation SME on computer systems onsite utilized to support GMP manufacturing, such as MES & Delta V.
Oversee and perform computer system validation activities.
Ensure the approach and execution aligns to applicable regulations, GAMP 5, and site 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 c GMPs, 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.
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.
Technical Degree in Engineering/Life Sciences/Computer Science or greater preferred.
Min 3 days per week on site.
To apply for this inclusive and collaborative CSV Engineer job, do not hesitate to contact Cognizant today.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Industries: Pharmaceutical Manufacturing
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