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Manufacturing Validation Engineer

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Tata Consultancy Services

15d ago

  • Job
    Full-time
    Senior Level
  • Engineering
  • Cork

AI generated summary

  • You must have extensive validation and manufacturing engineering experience, expertise in Lean, knowledge of ISO standards, and strong documentation skills. Analysis using MINITAB and FDA/ISO familiarity are essential.
  • You will develop validation strategies, assist in process improvements, manage equipment life cycles, and support QA activities, including sampling, data analysis, and change control.

Requirements

  • 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 relations, 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:
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
  • Ability to analyze Capability data using MINITAB
  • Ability to interpret Engineering drawings/specifications
  • Familiarity in areas of various inspection techniques
  • Strong interpersonal skills to build and maintain positive, collaborative relationships with suppliers while holding them accountable for quality standards.
  • Nice to have: Work experience in the medical device industry

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.

FAQs

What is the job title for this position?

The job title is Manufacturing Validation Engineer.

What type of employment is offered for this position?

This position is a permanent role.

Where is the job located?

The job is located in Cork, Ireland and is fully onsite.

What kind of experience is required for the Manufacturing Validation Engineer role?

Extensive experience in validation and manufacturing engineering within a regulated industry is required.

Is experience in the medical device industry preferred?

Yes, experience in the medical device industry is considered a nice to have but is not mandatory.

What are the critical skills needed for this role?

Critical skills include knowledge in Process, Equipment and Test Method Validation, Lean expertise, and familiarity with ISO standards like ISO 9001 and ISO 13485.

What are the main responsibilities of the Manufacturing Validation Engineer?

Responsibilities include developing validation strategies, managing asset life cycles for new equipment, and preparing validation documentation, among others.

What tools or software should a candidate be familiar with?

Candidates should have the ability to analyze capability data using MINITAB and interpret engineering drawings/specifications.

What are the rewards and benefits offered for this position?

The company offers competitive salary packages, including pension, health care, life assurance, laptop, phone, and access to extensive training resources.

What is the company's stance on diversity and inclusion?

The company is committed to building an equitable culture where everyone can thrive and has various employee networks focused on diversity and inclusion.

How will applicants be notified about their application status?

Due to a high volume of applications, the company will not contact each applicant individually; if there is no response within 30 days, it should be deemed unsuccessful.

Is there an opportunity for career growth in this role?

Yes, the role provides opportunities to grow your career while being exposed to new technologies and challenges.

Is there a support system for adjustments during the application process?

Yes, candidates can request adjustments to the application process or during interviews by contacting the company with the subject line "Adjustment Request."

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Tata Consultancy Services

Consulting
Industry
10,001+
Employees
1968
Founded Year

Mission & Purpose

Tata Consultancy Services is an IT services, consulting and business solutions organization that has been partnering with many of the world’s largest businesses in their transformation journeys for over 56 years. Our consulting-led, cognitive powered, portfolio of business, technology and engineering services and solutions is delivered through our unique Location Independent Agile™ delivery model, recognized as a benchmark of excellence in software development. A part of the Tata group, India's largest multinational business group, TCS has over 601,000 of the world’s best-trained consultants in 55 countries.