Validation Engineer (Biotech)

TL;DR

Validation Engineer (Biotech): Supporting the validation of facilities, utilities, and centrifuge equipment for a pharmaceutical implementation project with an accent on system lifecycle documentation and regulatory compliance. Focus on executing protocols within the KNEAT platform, performing risk assessments, and ensuring adherence to cGMP standards.

Location: Must be authorized to work in the U.S. (Minneapolis, MN)

Salary: $90,000–$105,000

Company

hirify.global provides essential services to the life sciences industry to ensure health care products are developed, manufactured, and distributed in compliance with regulatory standards.

What you will do

• Support validation activities for facilities, utilities, and centrifuge equipment systems.
• Develop, author, and execute validation protocols and reports using the KNEAT platform.
• Manage lifecycle deliverables from risk assessment through commissioning and qualification (IQ/OQ/PQ).
• Collaborate with cross-functional teams to ensure project timelines and quality standards are met.
• Identify and mitigate validation-related risks using a risk-based approach.
• Support deviation investigations, change controls, and audit documentation reviews.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 3+ years of validation, CQV, or qualification experience in regulated manufacturing environments.
• Hands-on experience with KNEAT for protocol development and execution.
• Strong understanding of cGMP regulations, FDA, and ISPE principles.
• Must be authorized to work in the U.S.
• Excellent technical writing and documentation skills.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance with 100% premium coverage for employees.
• 401(k) plan with company matching.
• Paid Time Off, sick leave, and paid holidays.
• Education assistance and professional development support.
• Fitness benefits including gym membership discounts.
• Pet insurance and various financial perks.