Dillon Engineering Services Hiring for CSV Engineer Job at Ringaskiddy , Ireland Full Time

Our client, a major multinational medical device company is seeking to hire a CSV Engineer. The successful engineer will be site based and will be rewarded with a longterm contract and a highly competitive hourly rate.

The QA Computer System Validation Engineer will play a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and system changes. Providing support for the validation activities associated with equipment & systems ensuring that all compliance issues and requirements of company validation policies and procedures.

Roles & Responsibilities

• Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.

• Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)

• Assist in development of validation strategy and validation plan for computer system validations.

• Assist in resolution of deviations/ exceptions during qualification activities

• Assist with change control activities in accordance with site procedures
• Support the QA Validation team leader in driving improvements within the Validation and Change

• Control processes to streamline the validation activities associated with system changes and new technology development.

• Computer System Validation input for equipment and computer systems including new technologies

Required Education & Qualifications

• Hons. Degree Quality/ Manufacturing / Engineering / Science or related field

• Minimum 3 years of related industry experience.

• In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry.

• Strong knowledge of system development life cycle and GAMP.
• Minimum 3 years validation experience with automated manufacturing systems.
• High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations.

To explore this role in strict confidence please contact Diarmaid directly on 085-1187741.

Job Type: Full-time

Salary: €40.00-€60.00 per hour

Additional pay:

• Overtime pay

Benefits:

• Flexible schedule
• On-site parking

Schedule:

• Monday to Friday
• No weekends
• Overtime

Education:

• Bachelor’s (preferred)

Experience:

• CSV: 3 years (preferred)
• pharma or medtech: 3 years (required)

Licence/Certification:

• eligible to work in Ireland without visa assistance (required)

Work remotely:

• No