Manufacturing Validation Engineer (270225)
Role: Manufacturing Validation Engineer
Job Type: Permanent
Location: Cork, Ireland (Fully Onsite)
* Ready to utilise your experience in Process, Equipment and Test Method Validation?
* Are you looking for an exciting opportunity to develop your skills as a Manufacturing Engineer?
Join us as a Manufacturing Validation Engineer
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.
* Be part of an exciting team where you will be challenged every day
* Work closely with the range of teams within the business to bring products to life.
* Grow your career, while being exposed to new technologies.
The Role
The Validation Engineer should be able to manage asset life cycles for new equipment (URS, RA, IQ, OQ and PQ) aligning to business SOPs. The role will involve reviewing and approving documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls) and ensuring validation activities are completed in compliance with US and EU regulations, GBSC procedures and EHS requirements.
The resources we are seeking ideally have familiarity with customer procedures.
Key responsibilities:
* Assist in development of validation strategy and validation plan for equipment and process validations.
* Assist in the development of sampling plans, test plans and data analysis related to process validation.
* Support in process improvements, process optimization, lean improvements, cycle time reduction.
* Perform capability studies.
* Assist in resolution of deviations/exceptions during qualification activities.
* Assist with change control activities in accordance with site procedures.
* Prepare periodic validation review documentation for approval by the business units.
* Maintain site validation registry.
* Manage asset life cycles for new equipment (URS, RA, IQ, OQ and PQ).
* Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
Your Profile
Key skills/knowledge/experience:
* Must have: Extensive experience in validation and manufacturing Engineering within regulated industry.
* Must have: Experience in Process, Equipment and Test Method Validation.
* Be a Lean expert.
* Validation and Compliance Knowledge.
* Compliance with US and EU regulations, GBSC procedures and EHS requirements.
* ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices).
* Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
* Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports. Proficiency in technical writing is key.
* Working Knowledge:
o Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
o Ability to analyze Capability data using MINITAB.
o Ability to interpret Engineering drawings/specifications.
o Familiarity in areas of various inspection techniques.
o Strong interpersonal skills to build and maintain positive, collaborative relationships with suppliers while holding them accountable for quality standards.
o Nice to have: 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 with the subject line: “Adjustment Request” or liaise with recruiter 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. #J-18808-Ljbffr