Senior Validation Engineer

The Role:

• Senior Validation Engineer
• Galway
• Hybrid role with some remote working possible
• Permanent or Contractor Role

Role Brief:

The successful candidate will have a senior level of responsibility for the Validation Program including Computer Systems Validation (CSV)and general Quality Assurance activities.

You will also have responsibility for the coordination and direction and active participation in the validation and qualification of equipment utilities processes and software.

You be responsible for ensuring conformance to quality systems liaising with various departments giving guidance reviewing documentation and ensuring the company validation policies & procedures are being adhered to.

Skills Brief:

• Active participation in the Validation Program and general Quality Assurance activities.
• Validation of a range of computer systems
• Coordination / direction and active participation in the validation and qualification of equipment utilities processes and software in compliance with client policies FDA European cGMP and GAMP standards.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• QA support for validation investigations and implementation of corrective actions.
• Creation/Review/Approval of various validation and qualification documents
• Management of validation exception event and change control processes.
• Documenting all activities in line with cGMP requirements.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing quality safety and training systems.

Person Brief:

Candidates must have a relevant science or engineering tertiary qualification with a minimum of 5 years experience in the pharmaceutical or life sciences industry with strong experience of both General andComputer Systems Validation (CSV). Experience in Equipment & Process Validation would also be beneficial. Experience of GxP Computerised Systems and GAMP 5 is essential.

The ideal candidate will have excellent collaboration and communication skills with a demonstrated understanding of manufacturing processes and related process equipment. In addition to this strong attention to detail and an excellent understanding of validation concepts and documentation is required.

The role will be based in Galway and is hybrid with some remote working possible. You should be living within a reasonable commute of the Galway area and be available to be onsite as required which could be up to 5 days a week at times.

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 worlds 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 OEMs and Technology providers.