What are the responsibilities and job description for the Process Validation Engineer position at Michael Page?
Join a fast-growing medical device company as a Senior Process Validation Engineer, leading validation efforts to ensure compliance with FDA and ISO 13485 standards for cutting-edge surgical instruments. This onsite role offers opportunities to drive quality improvements, mentor teams, and contribute to innovative healthcare solutions in a collaborative environment.
Client Details
My client, an innovative medical device company, based in Pittsford, NY, specializes in developing state-of-the-art minimally invasive surgical instruments. With over 500 employees and a rapidly growing campus spanning 10 buildings on 95 acres, they are dedicated to improving patient outcomes through cutting-edge research, development, and manufacturing in an ISO 13485-certified environment.
Description
The key responsibilities of the Senior Process Validation Engineer are :
- Develop and execute Master Validation Plans (MVP) for medical device manufacturing processes, equipment, facilities, and cleanrooms.
- Write, review, and analyze validation protocols and reports to ensure compliance with FDA and ISO 13485 standards.
- Conduct and oversee validation testing, including statistical analysis, to verify process reliability and performance.
- Drive process improvement initiatives by identifying and implementing corrective and preventative actions (CAPA).
- Collaborate with cross-functional teams to support manufacturing efficiency, quality audits, and regulatory compliance efforts.
- Mentor and train less experienced team members in validation methodologies and best practices.
If interested, please apply using the link below. Qualified applicant will be contacted within 24-48 hours of submittal.
Profile
The successful Senior Process Validation Engineer will have :
Job Offer
On offer for the Sr. Validation Process Engineer is :
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
