DeltaV CSV Engineer 1685

Why SimoTech

What
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, benefits, career
progression, educational support and much more.

DeltaV CSV Engineer 1685

SimoTech require an DeltaV CSV Engineer to join
our team, supporting a biotech manufacturing facility for our multinational
biopharma client based in Limerick. 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 framework,
ensuring their compliance with pharmaceutical industry standards and
regulations. The ideal candidate will have extensive experience as a DeltaV CSV
Engineer in a pharmaceutical environment. The role offers a hybrid working
model.

Key Responsibilities

• Create and execute validation strategies for any
  new or existing process automation computerised systems.
  
• Assist with the implementation and validation of
  systems including DeltaV, Siemens PLC, Pi etc.
  
• Write and review 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.
  
• Creation of traceability matrices.
  
• Change controls and impact assessments for
  validated systems.
  
• Create and execute test cases for the verification
  of system functionality and data integrity.
  
• Preparation of validation summary reports.
  
• Provide support for audits and inspections from a
  validation perspective.
  
• Ensure all work is completed in compliance with
  industry standards and regulations including 21 CFR Part 11, GAMP5, and EU
  Annex 11.
  
• Provide validation and industry standards &
  regulations training to relevant team members.
  
• Work in conjunction with the Quality Assurance team
  to identify and amend any compliance gaps and to improve validation processes.
  
  

Requirements

Benefits

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