TMK IPSCO

Validation Engineer 2 - Product R&D

Full-time · Bedford, MA
✓ Verified live on the employer's own system · added 25 days ago
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Mid-level · 4+ yrs exp

Requirements

Education: Bachelor's degree

Experience: 4+ years

What this role involves

FDA

Skills & tools

Materials ScienceHazard AnalysisRoot Cause AnalysisRecordkeepingStatistical AnalysisTroubleshooting
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Full job description

Who You Are
Minimum
Qualifications:

- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 4+ years of experience in process or product development/validation

-OR-

- Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 3+ years of experience in process or product development/validation

-AND-

- 2+ years of experience with FMEA/risk analysis, product failure and root cause analysis - 3+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Preferred
Qualifications:

- Experience in Medical Device or Life Science industries - Experience with filtration and chromatography products

- Experience with Product Development Process (PDP) and working on cross functional teams - Experience in statistical analysis tools such as Capability, Gage R&R, DOE using Minitab - Capable in the development and execution of test method validations - Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry - Experience in equipment troubleshooting and repairs

Pay Range for this position: $84,900 - $127,300

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

What

we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

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This posting was published by TMK IPSCO on their own careers system and is shown here with a direct link to apply there. Employers: for corrections or removal, contact jobs@veritahire.com.