QA Validation Engineer

QA Validation Engineer in Sligo. Onsite role. Permanent or Contractor opportunity.

In this role you will be responsible for coordinating the development and maintenance of the site validation program for an NNIT client. Your role will be to ensure external regulatory, quality, and compliance requirements are met. You will be directly involved in the Coordination, implementation and development of the site Validation Program and general Quality Assurance activities.

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance/execution of the Site Validation Master Plan.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• Generation of validation investigations and implementation of corrective actions.
• Creation/Review/Approval of various quality documents and test data.
• Management of validation, exception event, and change control processes.
• Maintenance and tracking of validation equipment, if applicable.
• Documenting all activities in line with cGMP requirements.
• Maintaining the overall cGMP compliance of the production areas.

• Over 2 years plus validation experience in medical device plastics processing, molding or assembly operations.
• Proven knowledge of cGMP and regulatory requirements relating to the medical device industry.
• Strong documentation and review skills and experience.
• Experience of the development and maintenance of a site validation master plan within the Medical Devices or Life Sciences manufacturing sector.

Candidates must have a Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline with over 3 years' experience of Validation Engineering. You should have at least 2 years of experience of Validation activities for equipment found in Medical Devices, 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. He/she should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach.

The candidate should be based in Sligo or within a reasonable commute or be willing to relocate to the area as the role will be onsite.

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. NNIT offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT employs more than 1,800 people in Europe, Asia, and USA. SL Controls provides Equipment System Integration solutions to manufacturers, particularly those in the life sciences and technology sectors. The roles are based in various locations across Ireland as well as in our office in the USA. Our engineers deliver cutting-edge Smart Factory and Industry 4.0 solutions, so the work is rewarding and challenging. We also offer excellent opportunities for career progression.