At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.
Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives.Job Summary
The Validation Testing Engineer. will be based in Flex Juarez Sur will be focus on Define, design, implement Validated systems in compliance with FDA specifications, establish clear communication channels and propose system enhancements.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do:
- Define, design, implement Validated systems in compliance with FDA specifications and Change control
- Prepare Standard Operating procedures for the day-to-day maintenance of the applications and underlying systems.
- Ensure knowledge pertaining to new implementations and technologies are adequately shared with the team.
- Ensure adequate monitoring and controls are in place to ensure the stability of the solutions.
- Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers and cross functional teams.
- Ensure proper retention policies are in place to ensure systems are validated
- Propose system enhancements (software and hardware updates) that will improve the performance and reliability of the system.
- Make final decisions on administrative or operational matters and ensure operations' effective achievement of objectives.
Here is some of what you'll need (required):
- Bachelor's degree in related field.
- BS in Information Technology, Computer Science, OR Equivalent work experience
- 5+ years of
experience with software validation of enterprise systems
- Must have knowledge
of IT environments and how to maintain applications
- Must have in-depth
knowledge of FDA Part 11 and Part 820 regulations
- Outstanding Oral and
Written communication skills with a high attention to detail
- Software Validation
and compliance to 21 CFR Part 11, ERES, Part 820, and GAMP 5.
- Computerized Systems
- Working knowledge of
GAMP5, 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical
Device Software and System Development Life Cycle Process.
- Software Quality
Engineer working with Validation Engineers to complete the validation documents
and review and sign the IQ, OQ, PQ Protocols and Reports.
Here are a few of our preferred experiences:
- Advanced English
- Typically requires 5
years of experience
- Ability to work
- Ability to work in
- Seek improvements
- Masters' Degree
- Experience working
in a manufacturing environment
- Knowledge of
- Availability to
Here are a few examples of what you'll get for the great work you provide:
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing: email@example.com.
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