Job Description
Role: e-CSV Engineer
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Job Type: Permanent
Location: Blackpool, United Kingdom (On-site)
Ready to utilise your knowledge and hands on experience on CSV-E validation documents URS, IQ and more?
Are you passionate about directing, crafting, and executing Computer System Validation of GxP systems as per GAMP guidelines?
Join us as an e-CSV 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.
- Gain access to endless learning opportunities.
- Build and maintain a team of high-performing individuals.
- Build strong relationships with a diverse range of stakeholders.
The Role
As an e-CSV Engineer, you will work with the client to support e-CSV activities for industrial equipment required for manufacturing medical devices. You’re expected to take ownership of e-CSV deliverables on both development and execution and support on automation, equipment hardware, software, firmware throughout the validation lifecycle.
Key Responsibilities:
- Manage, plan, and execute Computer System Validation of GxP systems as per GAMP guidelines.
- Understand the SDLC and its various phases.
- Prepare the CSV-E validation documents URS, IQ, OQ, PQ, RTM.
- Perform the GxP Assessment, and ERES (Electronic Record and Electronic Signature) Assessment
- Review supplier functional spec to determine adherence to the standard.
- Create technical design specification, code review, system baseline description, software risk assessment.
- Assess the computer system quality management of suppliers as per international standards (ISO 13485) and perform Gap Analysis.
- Use qTest to manage testing, and bugs/ issues.
- Own responsibility for all relevant document approvals and closure in the PLM system.
- Effectively translate customer requirements into logical inputs for teams based remotely, including offshore team (if required).
- Own responsibility for adherence to timelines in a project environment and ensure project milestones are achieved.
- Maintain and present self and team matrices to Client and TCS management in structured and timely manner.
- Report issues to the Client and TCS management to ensure appropriate closure.
Your Profile
Key Skills/Knowledge/Experience:
- Relevant experience in e-CSV (preferably in medical device/Pharma) with strong knowledge in computer systems, hardware, equipment software and automation process.
- Understanding of SDLC and its various phases.
- Knowledge of validation lifecycle for industrial manufacturing equipment (preferably medical device).
- Experience in working with Industrial automation instruments.
- Experience in collaborating with cross functional teams such as, maintenance, supplier development, quality, packaging, labeling etc.
- Hands on Experience on PLM process.
- Proficient with MS Office applications such as MS Word, PowerPoint, Excel.
- Strong communication and inter-personal skills.
- Self-driven & ability to perform assigned responsibilities independently with minimal guidance.
- Flexibility to accommodate additional effort needed to meet project and organisational deadlines.
- Sense of urgency, self-awareness, adaptability and intellectual curiosity.
Good to have:
- Good technical writing skills with attention to detail.
- Experience of CMF (craniomaxillofacial products) will be an added advantage.
Rewards & Benefits
TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature paid holiday entitlement, pension contribution, private healthcare including dental & optical coverage, life assurance and income protection, laptop and phone, cycle-to-work scheme, exclusive discounts on gym memberships, discounted rates on car leasing options, staff discounts within the larger Tata network, and access to extensive training resources.
Diversity, Inclusion & Wellbeing
At TCS, we believe in building and sustaining a culture of equity and belonging where everyone can thrive. Our diversity motto is ‘Inclusion without Exception’.
You’ll find a welcoming culture and many internal volunteering and social networks to join. Our diversity, inclusion and social activities involve 12 employee networks including LGBTQ+ & Allies, mental health, disability & neurodiversity inclusion and many more, as well as health & wellness initiatives and sports events (we even sponsor the London Marathon).
We are open to all and treat applications equally, regardless of ethnicity, disability, gender identity, gender reassignment, age, sexual orientation, or beliefs.
If you are an applicant who needs a reasonable accommodation due to Disability or Neurodiverse Condition to complete an employment application, or during any phase of the hiring process, please contact us at hariharan.s8@tcs.comwith the subject line: “Reasonable Accommodation Request”.
Due to the 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.
Application Process
1. Online application > 2. Technical discussion > 3. Managerial discussion > 4. HR discussion (EP role – usually)
Join us and do more of what matters. Apply online now.