Process Validation Engineer

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:

• Experience: Brings 7-10+ years of validation experience, with expertise in process, equipment, and software validation for medical device manufacturing.
• Regulatory Knowledge: Understanding of FDA Quality System Regulations (QSR) and ISO 13485 standards, ensuring full compliance in validation activities.
• Analytical Thinker: Proficient in statistical tools like Minitab and capable of analyzing complex data to identify root causes and implement effective solutions.
• Mentor and Collaborator: Skilled at guiding less experienced team members while working cross-functionally to achieve project milestones and improve processes.
• Detail-Oriented Professional: Demonstrates exceptional technical writing, organizational, and communication skills for creating precise validation protocols, reports, and documentation.
• Innovative Problem-Solver: Identifies and implements process improvements to enhance product quality, reliability, and efficiency in a dynamic manufacturing environment.

Job Offer

On offer for the Sr. Validation Process Engineer is:

• Competitive 401k match to support long-term financial planning
• Potential Education Reimbursement
• Excellent PTO Package
• Strong health care benefits
• Opportunity to join a thriving manufacture with a history of long tenure

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.