CQV Engineers (Multiple Levels) (Biopharma Validation)

Location: Minneapolis, United States; hybrid work with onsite support required during commissioning, startup, and peak execution periods.

Company

hirify.global provides engineering, validation, and compliance services for pharmaceutical and biotechnology manufacturing and regulated healthcare products.

What you will do

• Author, review, execute, and close commissioning, qualification, and validation protocols and reports.
• Support installation, operational, and performance verification for facilities, utilities, equipment, and manufacturing systems.
• Perform field testing, analyze data, resolve discrepancies, and maintain traceability across requirements, risks, testing, and deliverables.
• Coordinate with engineering, quality, manufacturing, automation, project, and vendor teams.
• Support project schedules, commissioning readiness, turnover, startup, operational readiness, investigations, and audit activities.

Requirements

• Bachelor’s degree in engineering, biotechnology, biology, chemistry, pharmaceutical sciences, or a related technical discipline.
• Experience in biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities.
• Prior experience with the Kneat Gx digital validation platform is required.
• Experience with commissioning, facility, utility, equipment, cleaning, sterilization, computerized systems, temperature mapping, or automation validation.
• Experience with MES, SCADA, PLC-controlled systems, data integrity programs, or other GMP automation platforms.
• Ability to work in a hybrid environment and provide onsite support during key execution periods.

Culture & Benefits

• Work with a multicultural team of life sciences professionals across global operations.
• Opportunities are available from entry level through senior level, with responsibilities scaled to experience.
• Coaching, professional development, and tools to support career growth.
• Compensation and benefits are provided as part of the employment package.
• Equal employment opportunity and non-discrimination commitment.