Join to apply for the CSV Delta V Engineer 1639 role at Simo Tech.
Why Simo Tech Working at Simo Tech offers a collaborative culture based on respect, trust, and excellence.
We play a critical partnering role in supplying life‑changing products to patients.
In return, we provide excellent salary, benefits, career progression, educational support, and more.
CSV Engineer
Simo Tech has an opportunity for a Computer Systems Validation Engineer to join our team, supporting our client at a state‑of‑the‑art biotechnology site in Cork.
The successful candidate will have 2+ years' experience in a similar role within the life sciences industry and will support automation projects with a focus on validation activities.
This role involves validation support for automation systems, and requires strong skills in non‑conformance investigation and technical writing.
Key Responsibilities
Assist in creating and executing validation strategies for new and existing automation computerised systems.
Support the implementation and validation of Delta V DCS and related automation systems.
Write and review key validation documents, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Validation Plans.
Carry out risk assessments on validation activities.
Identify and resolve validation test deviations or failures.
Support the creation of traceability matrices and change controls for validated systems.
Prepare validation summary reports.
Provide support during audits and inspections from a validation perspective.
Ensure work is completed in compliance with industry standards and regulations, including 21 CFR Part 11, GAMP 5, and EU Annex 11.
Collaborate with the Quality Assurance team to identify and amend any compliance gaps and to improve validation processes.
Key Requirements
Bachelor's Degree in Engineering, Information Systems, Computer Science or Life Sciences.
Minimum of 2 years' experience as a CSV Engineer, supporting Delta V automation in a pharmaceutical environment.
Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity guidelines.
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.
Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
Long term project opportunity.
Positions available as a staff or contract engineer.
Competitive staff or contract rates.
Benefits
We offer competitive salary and benefits, a supportive work culture, opportunities for career progression and educational support.
What Simo Tech Can Offer
We provide a collaborative environment that encourages professional growth and offers a competitive compensation package.
Seniority level
Entry level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Automation Machinery Manufacturing
#J-18808-Ljbffr