Title: Process Validation Engineer

Location: Massachusetts

Duration: 12 Months

Job Overview:

We are seeking a Process Validation Engineer to support validation activities for manufacturing processes, equipment, software, and facilities. You will ensure all work complies with FDA and industry regulations and internal quality procedures. This role involves working with cross-functional teams, writing and executing validation protocols, analyzing data, and supporting audits.

Key Responsibilities:

• Plan and execute validation activities (IQ, OQ, PQ) for equipment, processes, and systems.
• Write and review protocols, reports, and related documentation.
• Analyze data and prepare technical reports to support validation conclusions.
• Participate in change control processes and risk assessments.
• Support audits and inspections by providing validation documentation.
• Work with teams across quality, engineering, and manufacturing departments.
• Maintain and update validation procedures and ensure documentation is audit-ready.
• Act as a technical expert for validation-related questions or issues.

Requirements:

• Bachelor’s degree in Engineering, Science, or a related field.
• 4–8 years of validation experience in a pharmaceutical or medical device company.
• Strong understanding of FDA regulations, GMP, and ISO 13485.
• Hands-on experience with equipment and process validation.
• Good writing, communication, and problem-solving skills.
• Able to work independently and manage multiple tasks.