Role Brief
Thesuccessful candidate will focus on the validation activities for a range of equipment solutions within a regulated Pharma environment.
You will bothhave responsibility for a number of activities and pieces of equipment whilealso supporting the wider Validation function and ensuring Validationactivities are closed out in line with the Validation Master Plans.
At its corethe role will involve drafting documentation (IQ, OQ etc), involvement in validationactivities in relation to the execution phase on new equipment and processimprovements on current equipment.
Skills Brief
Strong experience in the area of Equipment Validation in a regulated GMP environment (Pharma, Life Sciences, Medical Devices or Biotech)
Managing& coordinating the preparation, review & approval of ValidationMaster Plans
Generate,execute and review validation protocols and associated reports for relatedequipment and processes.
Managing& coordinating of all validation strategies & deliverables
Managing& coordinating the preparation, review & issuing of validationprotocols & reports
Managing& coordinating validation documentation (risk assessments,traceability matrices)
Managing& coordinating the review & approval of specifications associatedwith Equipment & Processes.
Managing& coordinating routine Internal Quality Audits of the facility toensure compliance & be proactive in resolving issues that may arise.
Providetechnical direction & hands-on assistance for testing projects
Person Brief
Candidates must have a Bachelor’s degree in ComputerScience, Electrical Engineering, Systems Engineering, Technology or a relateddiscipline with over 3 years’ experience of Equipment Validation.You must have at least 2 years of experience of Equipment Validation activities forequipment found in Pharmaceutical or other GMP regulated environments (Biotech,Biopharma, LifeSciences or Medical Devices).
The ideal candidate will have excellent collaboration andcommunication skills, strong attention to detail and an excellent understandingof validation concepts and documentation. He/she should also have provenability to solve complex technical & equipment qualification challengesusing a rational scientific approach.
The candidate should be based in Sligo or within areasonable commute or be willing to relocate to the area as the role will befully onsite nature. Only candidates currently meeting this criteria oravailable and able to relocate in a short timeframe can be considered.
About NNIT
NNIT is a public listed company who 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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