Validation Engineer

BEPC Inc. - Business Excellence Professional Consulting; Tucson (AZ); On-site; USD 53,726 - 57,859; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

BEPC Inc. - Business Excellence Professional Consulting is seeking a Validation Engineer to join their team in Tucson, AZ. This onsite role focuses on supporting process validation activities in a regulated manufacturing environment, ensuring compliance with FDA and other standards. The ideal candidate will have a Bachelor's degree in Engineering or Life Science, 1-3 years of experience in medical devices, pharma, or biotech, and strong technical writing and analytical skills. The position offers a W2 contract with a pay rate of $39.00 - $42.00 per hour, along with benefits including medical and dental insurance.

Responsibilities

• Develop, write, review, and execute process validation protocols and reports.
• Conduct risk assessments and develop validation strategies for processes.
• Analyze process validation data ensuring accuracy and regulatory compliance.
• Collaborate with teams to resolve validation issues and implement actions.
• Participate in optimization and continuous improvement initiatives.
• Ensure compliance with FDA, ISO, and other regulatory guidelines.
• Provide training on validation processes and procedures.
• Maintain process validation documentation for audits and inspections.

Skills

Technical writing

Analytical skills

Problem-solving skills

Knowledge of cGMP

Understanding of process validation principles

Education

Bachelor’s Degree in Engineering or Life Science

Job description

BEPC is actively looking for Validation Engineer, in Tucson, AZ area!

W2 Contract – 12 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate: $39.00 - $42.00 /hour - Determined based on experience (Paid weekly)

Work Model: Onsite role

Note: This is a W2 only role — C2C, C2H will not be considered

Summary of the position

BEPC is seeking a highly motivated Validation Engineer to join our client’s site in Tucson, AZ. This role will support process validation activities in a regulated manufacturing environment to ensure compliance and drive operational integrity.

We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity.

Summary of Duties and 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.

Main Qualifications

• Education: Bachelor’s Degree in Engineering or Life Science.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Strong understanding of process validation principles, techniques, and industry standards.

Preferred Qualifications

• 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA).