Overview
Validation Engineer Randstad Not Jobs in Princeton, New Jersey, USA at Savvy, Inc.
Position: Validation Engineer Randstad USA Princeton, NJ Interested Not Interested
Job Summary
A Validation Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery. Remote work. This position is responsible for overseeing and guiding supplier process validations (IQ/OQ/PQ) for sterile barrier packaging manufacturing, ensuring compliance with FDA, ISO 13485, and ISO 11607 standards while collaborating with suppliers to execute validation requirements and resolve technical challenges.
location:
Remote
job type:
Contract
salary: $39.99 – 55.86 per hour
work hours: 8am to 5pm
education:
Bachelors
Responsibilities
Collaborate with suppliers to review and approve validation documentation, including protocols and reports.
Provide hands-on support to suppliers during validation activities, ensuring compliance with regulatory standards (FDA, ISO 13485).
Lead technical discussions with suppliers to address validation challenges and resolve issues.
Coordinate post-design verification activities, including updates to engineering drawings to reflect CTQs and associated risk levels.
Deliver progress updates to internal stakeholders, ensuring alignment with program timelines and quality standards.
Conduct focused process audits to evaluate supplier compliance with validation protocols.
Skills
Strong understanding of sterile barrier packaging materials and manufacturing processes.
Proficiency in regulatory standards, including FDA, ISO 13485, and ISO 11607.
Experience with technical drawings, CTQs, and risk management principles.
Strong analytical skills with experience using data for validation decisions.
Ability to work collaboratively with suppliers and cross-functional teams.
Education
And Experience
Degree in Mechanical, Industrial Engineering, or a related Science discipline.
8+ years of experience in process validation (IQ/OQ/PQ) within a regulated industry (medical devices, pharmaceuticals).
Qualifications
Experience level:
Experienced
Education:
Bachelors
Skills
Validation
Compliance
Manufacturing
Equal Opportunity
Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
This posting is open for thirty (30) days.
#J-18808-Ljbffr
Title: Validation Engineer Randstad Not
Company: Savvy, Inc.
Location: Princeton, New Jersey, USA
Category: Engineering, Quality Assurance – QA/QC
