Technical Writer & Validation Support (050225)
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?
We have an exciting role for you.
Careers at TCS: It means more
TCS is a purpose-led transformation company, built on belief. We do not just help businesses to transform through technology. We support them in making a meaningful difference to the people and communities they serve - our clients include some of the biggest brands in the UK and worldwide. For you, it means more to make an impact that matters, through challenging projects which demand ambitious innovation and thought leadership.
* Grow your career, while being exposed to new technologies.
* Be part of an exciting team where you will be challenged every day.
* Work with customers and identify opportunities to support their strategy and improve their processes across functions.
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 looking for someone who is self-driven. Ideally, the candidate has familiarity with client procedures (e.g., Vision Care or eye care etc). Key responsibilities include:
* Supporting validation from an automation perspective.
* Actively guiding the Añasco site 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.
In this role, you will work with a team built on collaboration, communication focus & motivated to deliver 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.
Rewards & Benefits
TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources, and discounts within the larger Tata network.
Diversity, Inclusion & Wellbeing
Tata Consultancy Services UK&I is committed to meeting the accessibility needs of all individuals in accordance with the Ireland Employment Equality Acts 1998-2011 (as amended) and the Equal Status Acts 2000-2012 (as amended). We believe in building and sustaining a culture of equity and belonging where everyone can thrive. Our diversity and inclusion motto is ‘Inclusion without Exception’. Our continued commitment to Culture and Diversity is reflected across our workforce implemented through equitable workplace policies and processes.
You’ll find a welcoming culture and many internal volunteering and social networks to join (these are optional). Our diversity, inclusion, and social activities include 12 employee networks such as gender diversity, LGBTQIA+ & Allies, mental health, disability & neurodiversity inclusion and many more, as well as health & wellness initiatives and sports events and we sponsor the London Marathon.
We welcome and embrace diversity in race, nationality, ethnicity, disability, neurodiversity, gender identity, age, physical ability, gender reassignment, sexual orientation. We are a disability inclusive employer and encourage disabled people to apply for this role.
If you are an applicant who needs any adjustments to the application process (including completing the application form) or interview, please contact us at UKI.recruitment@tcs.com with the subject line: “Adjustment Request” or liaise with recruiter Rebecca.mcclelland@tcs.com to request an adjustment. We welcome requests prior to you completing the application and at any stage of the recruitment process.
Next Steps
Due to a high volume of applications, we will be unable to contact each applicant individually on the status of their application. If you have not received a direct response within 30 days, then it should be deemed unsuccessful on this occasion.
Join us and do more of what matters. Apply online now.
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