Process Validation Engineer

Magenta Medical is seeking an Intermediate Process Validation Engineer to join our dynamic team.

The successful candidate will be responsible for ensuring that manufacturing processes, equipment, and products meet established quality standards and regulatory requirements. This role requires a strong background in process validation methodologies and a collaborative approach to work within cross-functional teams to drive continuous improvement and compliance.

Responsibilities

Validate manufacturing processes.
Participate in the development of new production processes, including Tech Transfer, PFMEA, PVMP, IQ, OQ, PQ, etc.
Develop, execute, and maintain process validation protocols and reports for new and existing products, ensuring compliance with regulatory requirements.
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to design and implement validation strategies.
Conduct risk assessments and identify critical process parameters to ensure product quality and consistency.
Provide technical support and guidance during audits and inspections related to process validation.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related field.
Minimum of 3 years of experience in process validation within the medical device or pharmaceutical industry.
Strong understanding of validation principles, methodologies, and regulatory requirements.
Experience with complex mechanical/material production processes (advantageous).
Familiarity with Process Validation Master Protocols (PVMP).
Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
Experience with Test Method Validation.
Proficiency in Design of Experiments (DOE) analyses.
Experience in writing protocols and reports.

Required Skills

Proficiency in CAD software (SolidWorks).
Experience with data analysis/statistical software (JMP or MiniTab).
Strong problem-solving, analytical, and troubleshooting skills.
Ability to collaborate effectively in cross-functional teams.
Strong written and verbal communication skills in English.
Excellent interpersonal skills.

Reports to:

Project Manager