Qa Validation Engineer

2 weeks ago

Dublin, Dublin City, Ireland Nnit Group Full time

Role Brief
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.
Core Tasks
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.
Skills Brief
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.
Person Brief
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.
About NNIT
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 consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls.
Together, these companies employ more than 1,800 people in Europe, Asia, and USA.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.
In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.
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