Engineer

Vaxxinona US, Inc.•Willmar, MN

2d•$52,000 - $96,000•Onsite

About The Position

This full-time position supports the qualification and validation of veterinary vaccine manufacturing equipment (autoclaves, bioreactors, freeze dryers, etc), processes, and systems by executing equipment commissioning, ensuring that equipment is properly installed (IQ), operates as designed (OQ), and performs as needed (PQ) within USDA regulatory requirements, ensuring vaccine delivery to customers throughout North America and the world.

Requirements

Bachelor’s degree in Engineering, Biotechnology, Biology, Chemistry or related technical discipline is required.
5+ years of qualification, validation, engineering, or biopharmaceutical manufacturing experience required.
Possess a clean, valid driver’s license for occasional travel to other Vaxxinova facilities.
Proven experience leading qualification programs in a regulated environment.
Bachelor’s degree in Engineering, Biotechnology, Biology, Chemistry, or related field preferred.
3-7 years of qualification, validation, manufacturing, or quality experience required.
Demonstrated technical writing and problem-solving
A high school diploma or equivalent, with at least 5 years of experience in manufacturing, maintenance, quality, or validation is required.
An A.S. degree or higher in a biological or engineering field is preferred, with no experience required.
Strengths in multi-tasking, troubleshooting and prioritization.
Ability to calculate offsets, concentrations, unit conversions, and other technical measurements.
Proficiency with Microsoft Office applications and computerized systems.
Strong verbal and written communication skills in English.
Perform work that requires standing, climbing, twisting, reaching, crouching, kneeling and lifting, pushing or pulling of equipment, typically while gowned for cleanroom operations.
Ability to adapt and respond positively to schedule changes.
Strong attention to detail and documentation practices.

Responsibilities

Lead qualification strategies for manufacturing equipment, utilities, and supporting systems.
Develop and approve qualification plans, protocols, reports, and risk assessments.
Serve as technical lead for equipment installations, capital projects, and major modifications.
Determine qualification requirements related to equipment changes and process improvements.
Lead investigations involving qualification deviations, calibration excursion, and equipment failures.
Serve as subject matter expert during audits and regulatory inspections.
Mentor technical staff and drive continuous improvement initiatives.
Independently execute qualification and requalification activities.
Author and revise qualification protocols, test plans, reports, and associated documentation.
Evaluate equipment modifications and determine qualification impact.
Perform periodic qualification assessments and recommend requalification strategies.
Coordinate qualification activities with Manufacturing and Quality Assurance.
Investigate qualification, calibration, and equipment performance issues.
Support technical transfer, process improvement with validation, and cross-functional projects.
Assist with the qualification and requalification activities for manufacturing equipment and utility systems.
Execute approved qualification protocols under supervision. Set up, operate, and tear down qualification test equipment. Properly document and file all records, working within a computerized maintenance management system and coordinating with Quality Assurance as needed.
Assist cross-departmental teams with experimental design and technical transfer projects.
Maintain spare parts, tools and equipment in a clean and organized manner.