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 in the Plainsboro, NJ area. This role requires a Bachelor's degree and 4-7 years of experience to generate, execute, and document equipment and process validation protocols, utilizing technical writing and statistical analysis while ensuring all new product and equipment introductions strictly comply with cGMP, QSR, and ISO standards.
location: Plainsboro, New Jersey
job type: Contract
salary: $57.64 - 80.52 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Protocol & Reporting: Generate, execute, route, and approve qualification/validation protocols and associated summary documentation (including deviation reports).
- Software Validation: Generate and execute software qualification documentation, including risk assessment, data integrity checks, and trace matrices.
- Statistical Analysis: Work with project teams to develop Design of Experiments (DOEs) and statistically sound tests.
- Testing Support: Complete test method validation, gauge R&R (repeatability and reproducibility) studies, and other qualifications to support product testing.
- Sampling Plans: Develop statistically based sampling plans for in-process and final test sequencing.
- Project Coordination: Coordinate scheduling, allocate materials, and align personnel to successfully complete validation assignments.
- Compliance: Ensure all projects comply with cGMP, cGLP, QSR (including Design Controls), ISO, and other applicable regulatory requirements.
- Documentation Support: Support and address feedback on validation and engineering documentation.
- Technical Justification: Technically sound in understanding scientific rationale and justifying criteria from a quantitative standpoint.
- Regulatory Awareness: Familiar with the process flow of a medical device organization, including the regulatory impact of change and the documentation path for compliant processes.
- Documentation Experience: Possess technical writing experience in protocol and procedure generation, along with some experience in master plan generation and the change control life cycle.
- Risk Management: Understand the concepts of risk management and the ability to identify and classify critical parameters.
- Testing Tools: Experience using temperature mapping equipment (e.g., Kaye Validators and Valprobes) is highly desired.
- Soft Skills: Demonstrates excellent organizational and communication skills, results orientation, and an ability to resolve conflicts.
- Work Environment: Ability to thrive in a team environment while also working independently to research and investigate.
- Clean Room (Plus): Gown qualification and an understanding of clean room practice and cGMP environments is a plus.
- Education: Bachelor's Degree in Engineering (Biomedical, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry).
- Experience: 4 to 7 years of experience in a Validation or Quality Assurance role, preferably within a medical device or pharmaceutical environment.
- Supervision: Works under direct supervision of the Manager, Quality Engineering; no supervisory duties are required.
- Tracking: Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
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 HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
