Senior CSV Engineer 1579

Cork
Permanent
Full-time

1 month ago

About SimoTechSimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.Why SimoTechWhat is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients' life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.Senior CSV Engineer 1579SimoTech require a Senior CSV Engineer to join our team, supporting a biotech manufacturing facility for our multinational biopharma client based in Cork. You will join a state-of-the-art facility, incorporating new technologies, with a specific focus on operational flexibility, environmental sustainability, and fast track delivery concepts.The successful candidate will support the validation of computerised systems within the process automation and manufacturing execution system (MES) framework, ensuring their compliance with pharmaceutical industry standards and regulations. The ideal candidate will have at least 5 years' experience as a CSV Engineer in a pharmaceutical environment. The role offers a hybrid working model.Key Responsibilities

Be the subject matter expert on the development, implementation, and execution of comprehensive CSV validation strategies and plans for new and existing computerised systems supporting manufacturing operations.
Oversee validation activities for MES and other critical control and data management systems.
Author and review detailed validation documents including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Validation Plans.
Manage deviation investigations and corrective actions related to validation activities.
Lead change control impact assessments and support ongoing compliance of validated systems Develop and maintain traceability matrices to ensure full test coverage and regulatory compliance.
Support internal and external audits and regulatory inspections, acting as a subject matter expert in CSV.
Provide mentorship and training to junior CSV engineers on validation processes and industry regulations.
Ensure all validation activities comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.
Collaborate closely with the Quality Assurance team to continuously improve validation methodologies and compliance frameworks.

Qualifications

Bachelor's Degree in Engineering, Information Systems, Computer Science or Life Sciences.
Minimum of 5 years' experience as a CSV Engineer in a pharmaceutical environment.
Experience supporting process automation systems and manufacturing technologies from a CSV perspective.
Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
Hands on experience validating MES (such as TULIP, Syncade, Pharmasuite, Pas-X) and other critical control and data management systems.
Working knowledge of risk management practices and tools such as FMEA.
Strong written and verbal communication skills with the ability to work in a cross-functional team.
Strong attention to detail, organisational and problem-solving skills.

What SimoTech Can Offer

Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
Opportunity to work with large corporate clients on exciting capital projects.

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