Job Details
Role: Technical Writer & Validation Support
Job Type: Permanent
Location: Limerick, Ireland (Onsite)
The Role
We are looking to hire a Technical Writer & Validation Support with previous experience supporting the validation of major capital automation projects. We are seeking 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 developing 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.
* 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 completion.
* Validation documentation creation.
* IQ | OQ | PQ documentation creation.
* IQ | OQ | PQ documentation plan completion.
* 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
* 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).
* 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.).
* Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.
* Familiarity with documentation standards such as DITA (Darwin Information Typing Architecture) or the S1000D standard.
* Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation.
Validation Support Skills
* 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.
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