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 involves conducting equipment and process validations, ensuring regulatory compliance, and managing documentation and testing for new products in a medical device manufacturing environment.
location: Plainsboro, New Jersey
job type: Contract
salary: $54.97 - 76.80 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform equipment and process qualification for new equipment, products, and processes in a manufacturing facility.
- Generate and execute validation protocols and manage the routing and approval of summary documentation.
- Read and interpret engineering P&IDs and turnover documentation.
- Collaborate with project teams to develop Design of Experiments (DOEs) and statistically sound tests.
- Conduct test method validation, gauge R&R studies, and other qualifications for product testing.
- Coordinate scheduling, material allocation, and personnel for validation assignments.
- Develop statistically based sampling plans for in-process and final testing.
- Ensure compliance with cGMP, cGLP, QSR, ISO, and other regulatory requirements.
- Generate, review, and approve protocols, deviations, and summary reports.
- Support change control, non-conformance, and CAPA activities.
- Understanding of cleanroom practices and cGMP environments.
- Knowledge of risk management and ability to identify critical parameters in production.
- Proficiency in technical writing for protocol and procedure generation.
- strong organizational and communication skills.
- Ability to resolve conflicts and focus on quality principles.
- Competence in tracking and updating schedules for management visibility.
- Bachelor's Degree in Engineering (Biomedical, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry).
- 4 to 7 years of experience in Validation or Quality Assurance for medical devices or pharmaceuticals.
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
