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Offshore Engineer
3 months ago
Role: e-CSV Engineer Job Type: Permanent
Are you passionate about directing, crafting, and executing Computer System Validation of GxP systems as per GAMP guidelines?
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.
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.
Manage, plan, and execute Computer System Validation of GxP systems as per GAMP guidelines.
Perform the GxP Assessment, and ERES (Electronic Record and Electronic Signature) Assessment
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.
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.
Relevant experience in e-CSV (preferably in medical device/Pharma) with strong knowledge in computer systems, hardware, equipment software and automation process.
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.
Proficient with MS Office applications such as MS Word, PowerPoint, Excel.
Flexibility to accommodate additional effort needed to meet project and organisational deadlines.
Good technical writing skills with attention to detail.
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.com with the subject line: “Reasonable Accommodation Request”.
Online application 2. Apply online now.
