Validation equipment specialist

About Us

We are a growing 100% employee-owned organization established in the year 1996. Our workforce has expanded over the years and currently consists of nearly 700 employees across the globe.


Our Approach

We put our clients' interests first and do not stop until we deliver satisfactory results. We adhere to our core principles:

* We operate with integrity
* We serve each other
* We contribute to society
* We strive for long-term growth

With employee ownership, every individual's success contributes to the collective success.


Job Role

We are seeking a qualified Validation Engineer to join our team in Ireland.


Key Responsibilities

1. Support and assist in ensuring Quality Control compliance for equipment qualification activities, adhering to safety and regulatory standards.
2. Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail.
3. Follow established procedures and protocols for new equipment qualification to embed quality practices within workflows.
4. Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications.
5. Support planning and organization of commissioning materials and consumables, ensuring they meet required quality standards.
6. Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards.
7. Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards.
8. Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes.
9. Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
10. Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld.
11. Provide support for quality assurance tasks throughout the equipment qualification process, ensuring consistent quality standards are maintained.


Required Skills and Qualifications

* Bachelor's or Master's degree in a relevant science or engineering field, or equivalent experience.
* At least 2 years of industry-related experience in a similar role.
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
* Strong problem-solving skills with a focus on Quality Control.
* Customer-service oriented and able to collaborate well with internal teams and external vendors.
* Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience.
* Willing and able to travel domestically and internationally, if required.


Benefits

* Pension Fund
* Medical Aid / Health Care
* Dental Care