Validation Engineer

The Role:

• Validation Engineer

• The Netherlands, Zwolle

• Permanent/Contract

• Fully onsite role

Role Brief:

The successful candidate will be responsible for setting up/writing the test protocols for FAT and Validation (OQ) for the SCADA systems. Reporting to the Validation Manager you will be tasked with the execution of a large scale project covering all aspects of the production line.

Responsibilities:

• Provide direction, documentation, execution and review for plant validation activities.
• Manage and co-ordinate the Validation Change Control System, Validation Master Plan and associated schedule and all related documentation.
• Manage and support the execution of validation protocols (FAT/ES/IQ/OQ/PQ)
• Responsible for the creation of validation packages and review of all validation protocols and packages.
• Support the CAPA and Quality Metrics programme as required
• Support QA IT Systems (M-FILES) through which Validation Change Control is documented. This also involves the development and support of plant SME’s and general users
• Assist in the fine tuning and validation of the software
• Collaborate with other stakeholders to ensure the project progresses in a timely and effective manner

Skills

• Experience integrating Item level serialization packaging line solutions
• Knowledge and experience working with OEM packaging equipment
• Experience managing and supporting the execution of validation protocols (FAT/ES/IQ/OQ/PQ).

Person Brief:

Candidates must have over 3 years’ experience in Validation Engineering/ Validation activities for equipment found in Pharmaceutical or other GMP regulated environments.

The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and an excellent understanding of validation concepts and documentation. You should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach.

Opportunity Brief:

This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.

Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.

We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.

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