Qualification Engineer

Your mission:

As a qualification & validation consultant, you’ll take a lead role in qualifying and validating equipment, systems and processes that are central to

biotech and pharmaceutical projects. This role is perfect for a detail-oriented, tech-savvy professional who loves making sure every component works seamlessly and meets the highest standards.

What You’ll Do:

Equipment & System Qualification

• Commission & validate: Whether it’s new equipment or existing systems, you’ll ensure everything is qualified, validated, and ready to perform.
• Installation qualification (IQ): Verify that equipment is installed precisely according to design specs—no detail is too small!
• Operational qualification (OQ): Put systems through their paces to confirm they operate within all specified limits.
• Performance qualification (PQ): Test for consistent, reliable performance under typical operating conditions, so we know systems are ready for action.
• Process Validation (PV): Demonstrate that the manufacturing process consistently produces products that meet quality standards, ensuring it performs reliably and remains in a state of control over time.

Master of documentation

• Qualification & validation protocols: You’ll develop and execute protocols that capture every detail of the qualification and validation processes.
• SOPs & records: Create and manage standard operating procedures, calibration logs, and maintenance records to keep everything compliant and organized.
• Compliance & calibration: Ensure all equipment is calibrated and maintained to meet ISO, GMP, and other regulatory standards.
• Change control records: Manage change control documentation to track and document any updates or modifications in the system.

Champion of continuous improvement

Your top skills:

• Background: You hold a master’s degree in a scientific or engineering field (e.g., bio-engineering, bioinformatics, industrial engineering, civil engineering, etc.).
• Validation Expertise: you have a first experience in equipment and/or system validation within life sciences or biotech.
• You’re not scared of some documentation: creating SOPs, validation plans, calibration records, and other technical documentation: you’re up for it.
• Analytical & problem-solver: you’re someone who digs deep to analyze processes and equipment, identifying quality gaps and implementing practical solutions.
• You are detail-oriented, eager to learn, and adaptable to new challenges.
• Team player & communicator: You can work easily across teams, from quality control to engineering, making sure every project stage aligns with the highest standards.