SRG, the leader in the Life Sciences human capital industry, is looking for a Medical Device Validation Engineer III to join our manufacturing team in Plainsboro, NJ. This position is directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility.

Location: Plainsboro, NJ

Contract: W2 only, we cannot do C2C for this position.

Must Haves:

• Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
• 4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
• Experience with qualifying medical device manufacturing equipment.
• familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process
• possess technical writing experience in protocol generation and procedure generation
• Some experience is required in master plan generation and the change control life cycle
• Calibration Software qualification experience
• Currently using ProCal but open to any calibration software
• Equipment/process qualification experience with a preference for experience with temperature mapping (KAYE validator probes).
• Must be experienced in one or more of the following areas of validation: Equipment Qualification, Process Qualification

Job Responsibilities:

• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
• Generation and execution of software qualification documentation including risk assessment, data integrity checks, trace matrices.
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
• Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments
• Develop statistically based sampling plans for in-process and final test sequencing.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements
• Support and address comments and suggestions associated with validation and engineering documentation.
• Protocol, Deviation, and summary report generation and approval.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.