Process Validation Engineer

Intellectt Inc; Jacksonville (FL); On-site; USD 90,000 - 125,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Process Validation Engineer in Jacksonville, FL. The role involves planning and executing validation activities, ensuring compliance with FDA regulations, and supporting cross-functional teams in maintaining quality standards. Ideal candidates should have a degree in engineering or science, strong problem-solving skills, and experience in validation processes.

Qualifications

• 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.

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.

Skills

Good writing

Communication

Problem-solving

Education

Bachelor’s degree in Engineering, Science, or a related field

Job description

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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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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