Process Validation Engineer

Process Validation Engineer

We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team. The Process Validation Engineer will be responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards. This role involves collaborating with cross-functional teams to support continuous improvement and maintenance of validated processes.

Responsibilities:

• Develop, write, review, and execute process validation/process verification protocols and reports.
• Conduct risk assessments and develop validation strategies for new and existing processes.
• Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
• Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
• Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
• Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
• Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
• Other duties as assigned by management.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 1-3 years of experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, etc.).
• Strong understanding of process validation principles, techniques, and industry standards.
• Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP).
• Excellent analytical, problem-solving, and critical-thinking skills.
• Strong written and verbal communication skills.
• Ability to work both independently and as part of a multidisciplinary team.
• Detail-oriented with strong organizational and time-management skills.
• Proficient in Microsoft Office Suite (Word and Excel), Google Workspace Preferred.