Job Details
Role: Technical Writer & Validation Support
Job Type: Permanent
Location: Limerick, Ireland (Onsite)
* Ready to utilise your skills as a Technical Writer?
* Are you looking for an exciting opportunity to grow within a dynamic team?
The Role
We are looking to hire Technical Writer & Validation support with previous experience supporting the validation of a major capital automation projects. We are looking for someone who is self-driven.
Key Responsibilities Include
* Supporting validation from an automation perspective.
* Guiding in transitioning from manual to automated validation methodologies, which includes the developing of the corresponding life cycle validation documentation and actively supporting the IQ | OQ | PQ.
* Collaborating with a CSV-specific resource (assigned). Therefore, understanding of CVS is important.
In this role, you will work with a team built on collaboration, communication focus & motivated to delivering excellent service and support.
Key Responsibilities
* Management of document tracker (Actively updating the document Listing of all documents for review | approval). This includes following up with reviewers / approvers, to ensure documents are reviewed / approved on time.
* FAT & SAT Documentation creation.
* FAT & SAT Protocol and Test Plan Completed.
* Validation documentation creation.
* IQ | OQ | PQ Documentation creation.
* IQ | OQ | PQ Documentation Plan Completed.
* Action plan developed for each of the key deliverables.
* Support the execution of IQ, OQ & PQ Testing.
Your Profile
Key Skills/knowledge/experience
* Experience supporting the validation of major capital automation projects.
* Must be self-driven under the supervision of the Validation & CSV Lead Engineer.
Technical Writing Skills
* Writing and Editing.
* Strong writing, grammar, and editing abilities to create clear and concise documentation.
* Ability to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies).
* Document Design and Formatting.
* Proficiency with documentation tools (e.g., Microsoft Word, Adobe FrameMaker, or Google Docs).
* Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.).
* Version Control.
* Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.
* Understanding of Documentation Standards.
* Familiarity with documentation standards such as DITA (Darwin Information Typing Architecture) or the S1000D standard.
* Ability to create and maintain templates, style guides, and consistency in documentation.
* Technical Communication Tools.
* Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation.
Validation Support Skills
* Validation Knowledge.
* Understanding of validation processes, especially in regulated industries (e.g., healthcare, pharmaceuticals, or software validation).
* Knowledge of validation protocols like IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
Quality Management Systems (QMS)
* Familiarity with industry standards like ISO 9001, FDA regulations (21 CFR Part 11), and GxP (Good Laboratory Practice, Good Manufacturing Practice) guidelines.
* Ability to support validation documentation, such as test plans, test scripts, and validation reports.
Testing and Documentation
* Knowledge of validation testing procedures and the ability to document results accurately.
* Experience with creating and maintaining test documentation, logs, and records.
Regulatory Compliance
* Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements.
Cross-Functional Collaboration
* Ability to work with technical teams (engineers, developers, QA, and project managers) to understand and document requirements, as well as support validation efforts.
Good To Have
* Certification in technical writing.
* Work experience in the medical device industry.
Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.
If you are interested in applying for this role, please do so via the relevant link. If you would like to discuss this role in confidence, please apply or contact Shaunagh.poyntz@eirevo.ie.
eir evo talent, eir evo and our clients are equal opportunity employers who seek to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data.
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