Lead Csv Engineer 1554

3 weeks ago

Cork, Cork, Ireland Simotech Full time

+353-21-4834930 Specialists in Life Science Automation and IT Systems
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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.
SimoTech require a
Lead CSV Engineer
, with 10+ years of CSV experience, to work with our client, a global leader in medical technology, on a global capital projects based in Cork.
Reporting to the Project Lead/Manager, the successful CSV Engineer will be a key member of the team focused on expansion and transformation of global operations.
The main purpose of this role will be to manage qualification of the GxP Computerised Systems involved in the plant expansion and improvement projects, including but not limited to Utilities System(s) / BMS changes and installations of packaging & filling equipment.
Key Responsibilities
Design, commissioning, qualification and validation documentation – drafting, reviewing, and approving CSV related elements of documentation as appropriate.
Co-ordinate and execute CSV related commissioning, qualification, and validation activities where applicable, including preparing of validation master plans and executing of DQ, FATs, and SATs.
Contribute to the scheduling, tracking, reporting, and achieving of project deadlines.
Provide input into the core aspects of operations, qualification, and validation SOP's.
Attend departmental and team meetings focused on CSV activities.
Serve as a CSV representative for internal technical group discussions.
Understand and apply industry specific compliance standards / regulations to all commissioning / qualification activities.
Conduct and participate in risk assessments, root cause analysis and investigations.
Review, approve and sign off protocols, reports, project change controls and deviations.
Proactively highlight any issues around compliance.
Participate in internal and external audits and inspections where required.
Work closely with the Client QA department and adhere to their requirements.
Qualifications
Degree level qualification in Science, Engineering or equivalent.
10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
Experience in process automation.
Understanding and experience in GAMP, GDP AND cGMP environments.
Experience with ISA S95 and S88 standards.
Experience of testing GAMP Category 3, 4 & 5 systems.
Knowledge of CFR 21 Part11.
Solid organisational skills including attention to detail and multitasking 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.
By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.
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