CSV Engineer
Posted a week ago by Headcount Solutions Limited
Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices.
Responsibilities:
-
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
-
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
-
Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
-
Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
-
Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
-
Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
-
Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
-
Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
-
Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
-
Qualification of laboratory analytical instruments (e.g. Cell Viability Analysers, Liquid Handlers etc.)
-
Qualification of manufacturing automation systems (e.g. DeltaV, MES etc.)
Requirements:
-
Bachelor's degree in Computer Science, Engineering, or a related field.
-
Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
-
Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
-
Familiarity with validation methodologies, including risk-based validation approaches.
-
Proficiency in creating and executing validation protocols and documenting validation activities.
-
Excellent analytical and problem-solving skills, with attention to detail.
-
Knowledge of software development life cycle (SDLC) and change control processes.
-
Understanding of data integrity principles and practices.
For further information please contact Mick on (phone number removed) or forward details in confidence to
- Type:
- Contract
- Start Date:
- ASAP
- Contract Length:
- 12-Month
- Contact Name:
- Login or register to view
- Telephone:
- Login or register to view
- Job Reference:
- 500MQ
- Job ID:
- 221127004
Remember: You should never send cash or cheques to a prospective employer, or provide any financial information. Please get in touch if you see any roles asking for payments or financial details from you. For more information, visit jobsaware.co.uk.