Syntricate Technologies

Manufacturing validation engineer

Syntricate Technologies$80K — $100K *
Manufacturing & Automotive
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor of Science in Engineering or relevant education/experience combination
  • 5+ years in medical device manufacturing
  • Expertise in cGMPs and clean room environments
  • Experience in Manufacturing Engineering and automation
  • Preferred experience in Test Method Validation and Measurement System Analysis
  • Knowledge of FDA Quality System Regulation and ISO 13485
  • Strong data analysis skills with proficiency in Excel and statistical packages (Minitab preferred)

Responsibilities

  • Conduct process and equipment qualification (IQ/OQ/PQ)
  • Develop test methods for Design Verification & Validation, Process Validation, and Production
  • Validate test methods for robust performance
  • Execute Engineering Builds and various validation studies
  • Author and release new test methods, edit/redline existing ones

Benefits

  • Full-time or contract position
  • Opportunity to work in a cutting-edge medical device environment
  • Chance to collaborate across diverse functional departments
  • Engagement in impactful validation processes that ensure product quality
  • Access to advanced tools and methodologies for manufacturing validation
Full Job Description
Hi,
We are looking for a Manufacturing Validation Engineer. Please let me know, if interested.
Manufacturing validation engineer
North Haven, CT
Full Time/Contract

Job duties:
  • Process and equipment qualification (IQ/OQ/PQ).
  • Development of test methods for Design V&V, Process Validation, and Production
  • Validation of test methods
  • Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
  • Authoring/releasing of new test methods and editing/redlining of old test methods

education/experience
  • This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
  • Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
  • Clean room environment experience
  • Manufacturing Engineering and automation experience.
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred.
  • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
  • Strong organizational skills, detail oriented.
  • Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
  • Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.

Thanks & Regards,

Sushil Kumar Kwatra
Syntricate Technologies Inc.
Email to: [email protected]
781-787-2012 (USA)

About Syntricate Technologies

Syntricate Technologies Careers

Joining Syntricate Technologies presents an unparalleled opportunity to advance a career in technology with a company at the forefront of digital innovation. Syntricate Technologies is renowned for its commitment to leadership, diversity, and leveraging technology to solve complex problems. This is where professionals come to not just seek job opportunities but to forge lasting careers in an environment that values growth and leadership.

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Syntricate Technologies is actively hiring and offers a variety of positions that cater to different skills and career aspirations. From entry-level roles to leadership positions, the potential for professional advancement is nearly limitless. Syntricate Technologies is not just a company; it's a place where talented individuals can thrive.

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At Syntricate Technologies, innovation isn't just another buzzword—it's the cornerstone of the company culture. Employees are encouraged to push the boundaries of what is possible, bringing groundbreaking solutions to the table. With a team of dedicated professionals, Syntricate Technologies fosters a culture of continuous improvement and professional growth.

Diversity and Inclusion

Syntricate Technologies believes that diversity fuels innovation. With a commitment to creating a diverse and inclusive workplace, the company actively seeks to hire individuals from various backgrounds and experiences. Diversity training is integral, ensuring that all team members feel valued and understood.

Internship Programs and Employment Benefits

For those starting their careers, Syntricate Technologies offers robust internship programs that provide real-world experience and networking opportunities. Interns at Syntricate Technologies gain invaluable industry insights and professional skills that are crucial for future employment. Full-time employees enjoy a comprehensive benefits package that supports both their professional and personal lives. Benefits at Syntricate Technologies are designed to ensure employees are healthy, happy, and secure.

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