Job Title: Technical Writer & Validation Support
Location: Limerick, Ireland (Onsite)
We are seeking a skilled Technical Writer & Validation Support to join our team. As a key member of our team, you will be responsible for supporting the validation of major capital automation projects.
Key Responsibilities:
* Supporting validation from an automation perspective.
* Guiding in transitioning from manual to automated validation methodologies, including developing life cycle validation documentation and actively supporting IQ | OQ | PQ.
* Collaborating with a CSV-specific resource (assigned).
* Managing document tracker (actively updating the document listing of all documents for review/approval).
* Creating FAT & SAT Documentation, Protocol, and Test Plan.
* Developing action plans for key deliverables.
* Supporting the execution of IQ, OQ & PQ Testing.
Requirements:
* Experience supporting the validation of major capital automation projects.
* Self-driven under the supervision of the Validation & CSV Lead Engineer.
* Technical writing skills, including strong writing, grammar, and editing abilities.
* Ability to adapt writing style to various audiences.
* Document design and formatting proficiency.
* Knowledge of design principles.
* Version control familiarity.
* Understanding of documentation standards.
* Ability to create and maintain templates, style guides, and consistency in documentation.
* Experience with technical communication tools.
* Validation support skills, including knowledge of validation processes and protocols.
* Quality management systems familiarity.
* Regulatory compliance knowledge.
* Cross-functional collaboration ability.
Preferred Qualifications:
* Certification in technical writing.
* Work experience in the medical device industry.