CQV Engineer 1590

Cork
Permanent
Full-time

21 days ago

About SimoTechSimoTech 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 SimoTechWhat 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.CQV Engineer 1590SimoTech has a new opportunity for an experienced CQV Engineer to serve as the subject matter expert on all project commissioning and qualification activities and resource management, for a biopharmaceutical client based in Co. Cork.The successful candidate will have a minimum of 5 years' experience leading CQV activities across all project functions, with a deep understanding of their requirements, development processes, and the ability to design and execute the most effective strategy.Key Responsibilities

Serve as the subject matter expert (SME) for all CQV requirements for Automated Visual Inspection validation, ensuring strategic alignment by collaborating with vendors, quality, validation, business, and automation teams, both globally and locally.
Ensure the design is executed without any compliance gaps, while supporting vendor assessment as needed throughout the project.
Lead validation preparation and design workshops during the basic design phase to ensure alignment with business objectives.
Create and maintain validation documentation packages, including standard protocols and reports, while managing project timelines and resource allocation.
Perform system testing and execute test scripts, investigate deviations and implement corrective actions, while initiating and managing change control processes for validated systems.
Create and maintain CQV related SOPs and work instructions.
Implement and ensure compliance with global standards across the project, support cross-stream project planning, and collaborate with operational users to understand and address their needs.
Provide periodical project status updates to the Project Manager.

Qualifications

Bachelors degree in Engineering, Computer Sciences, Life Sciences or similar.
Minimum 5 years' experience in the area of Pharmaceutical or Life Sciences CQV.
A strong understanding of regulatory compliance such as FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q7, and other relevant regulations.
Experience working in the validation of AVI systems, Fill/Finish and Packaging line is highly desirable.
Excellent verbal and written communication skills.
A proven ability to build strong cross-functional relationships, apply analytical problem-solving, make dynamic decisions, plan effectively, and manage stakeholder engagement and senior management reporting.

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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