FAQs
What type of employment is being offered for the Validation & CSV Lead Engineer role?
The position is a permanent employment opportunity.
Where is the location for this job?
The job is fully onsite in Limerick, Ireland.
What is the primary focus of the Validation & CSV Lead Engineer?
The role focuses on guiding the team in creating the master validation plan, validation strategy, and associated documentation for validating new machinery that inspects IOLs.
What key technical skills are required for this role?
Candidates must have experience in process and equipment validation, along with knowledge of computer system validation (CSV) methodologies.
Is experience in the medical device industry important for this position?
While it is listed as a "nice to have," experience in the medical device industry is beneficial for applicants.
What kind of certifications or familiarity is needed regarding regulations?
Familiarity with GxP guidelines, FDA 21 CFR Part 11, and ISO standards such as ISO 9001 and ISO 13485 is required.
What are the main responsibilities associated with this role?
Responsibilities include leading validation and qualification processes, collaborating with QA teams, developing validation documentation, and executing IQ, OQ, and PQ testing.
Will the selected candidate be required to lead a team?
Yes, the candidate will lead and coordinate validation activities with team members to ensure adequate resource assignment and task prioritization.
What benefits does TCS offer to its employees?
TCS offers competitive salary packages that include a pension, healthcare, life assurance, training resources, and discounts within the larger Tata network.
How does TCS approach diversity and inclusion in the workplace?
TCS is committed to building a culture of equity and belonging, welcoming diversity in race, nationality, gender identity, and more, with various employee networks and social activities available.
What should applicants do if they need adjustments during the application process?
Applicants needing adjustments should contact TCS with the subject line "Adjustment Request" or liaise with the recruiter for assistance.