Dublin  

About SimoTech

SimoTech 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 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, career progression, educational support and much more.
 

CSV Lead 1569

SimoTech has a new opportunity for an experienced CSV Lead to serve as the subject matter expert on validation for a Drug Product Facility Project for a biopharmaceutical client based in Co. Dublin.
 
The successful candidate will have at least 7+ years’ experience leading the full validation lifecycle of automation and digital systems for a new facility from strategy and planning through qualification, compliance, and operational handover.

Key Responsibilities

• Be the Subject Matter Expert (SME) for CSV activities on behalf of client.
• Provide strategic leadership and oversight for the entire CSV (CSA) scope of the project.
• Prepare plans, protocols, reports, risk assessments, qualification and validation documentation for the digital and automation scope on the project.
• Develop and implement a practical, effective CSV strategy that ensures compliance with site standards and regulatory requirements.
• Ensure a high standard of Automation & Digital deliverables.
• Prepare and clearly communicate the master plan and CSV strategy for the project and new facility implementation. Review and approve design deliverables (FS, DS, Drawings, etc.).
• Plan, attend and supervise FAT/SAT/IQ/OQ.
• Work closely with system owners, design team, C&Q team and all stakeholders in delivery of project.
• Ensure that project meet business requirements and delivers operational functionality.
• Manage change control and ensure high-quality documentation is maintained throughout all project phases.
• Develop plans and ensure the delivery of fully qualified and compliant systems.
• Collaborate with QA team to ensure compliance.
• Deliver key project documentation and manage handover to operations team.
• Work closely with commissioning and qualification teams to establish the facility.
• Provide support during facility start-up to ensure a smooth transition to operations.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 7 years’ experience working on validation.
• Experience working with Rockwell systems FT Batch, FT View, Control Logix & Plant Pax.
• Experience working with Werum Pas-X.
• Proven experience with drug production, especially fillfinish operations would be an advantage.
• Demonstrates proven leadership ability, excellent interpersonal and communication skills, and robust project experience.

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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