Role Brief:
The successful candidate will focus on validation activities for a range of equipment solutions within a regulated Pharma environment. They will be responsible for several activities and pieces of equipment while also supporting the wider Validation function and ensuring Validation activities are closed out in line with the Validation Master Plans.
Key Responsibilities:
* Drafting documentation, including IQ, OQ, etc.
* Involvement in validation activities related to the execution phase on new equipment and process improvements on current equipment.
Requirements:
* Managing and coordinating the preparation, review, and approval of Validation Master Plans
* Generating, executing, and reviewing validation protocols and associated reports for related equipment and processes.
* Managing and coordinating all validation strategies and deliverables
* Managing and coordinating the preparation, review, and issuing of validation protocols and reports
* Managing and coordinating validation documentation (risk assessments, traceability matrices)
* Managing and coordinating the review and approval of specifications associated with Equipment and Processes.
* Managing and coordinating routine Internal Quality Audits of the facility to ensure compliance and proactively resolving issues that may arise.
* Providing technical direction and hands-on assistance for testing projects
Person Specification:
Candidates must have a Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology, or a related discipline with over 3 years of Validation Engineering experience. They must have at least 2 years of experience in Validation activities for equipment found in Pharmaceutical or other GMP regulated environments (Biotech, Biopharma, Life Sciences, or Medical Devices).
* Excellent collaboration and communication skills
* Strong attention to detail
* An excellent understanding of validation concepts and documentation
* A proven ability to solve complex technical and equipment qualification challenges using a rational scientific approach
Opportunity:
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 Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
About NNIT:
NNIT is a public listed company specializing 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.