Commissioning Qualification Engineer (Biotech)

TL;DR

Commissioning Qualification Engineer (Biotech): Developing and executing commissioning and qualification protocols for life science utilities and equipment with an accent on KNEAT validation methodologies and risk-based strategies. Focus on generating comprehensive documentation, ensuring regulatory compliance, and providing remote technical support across cross-functional teams.

Location: Remote

Company

hirify.global is a professional services firm specializing in the pharmaceutical, medical device, and biotech industries.

What you will do

• Develop commissioning and qualification protocols using KNEAT platforms for utilities and equipment.
• Collaborate with cross-functional teams to integrate KNEAT solutions into project workflows.
• Assess risks associated with commissioning activities and develop effective mitigation strategies.
• Generate comprehensive validation documentation, including protocols and final reports.
• Provide remote technical support and regular project updates to key stakeholders.
• Ensure all activities remain in strict compliance with industry standards and regulations.

Requirements

• Bachelor's Degree in an engineering discipline.
• 3-5+ years of experience in commissioning and qualification within the pharmaceutical, biotech, or medical device sectors.
• Proven expertise in KNEAT systems and paperless commissioning processes.
• Strong understanding of risk-based qualification approaches and regulatory guidelines.
• Excellent technical writing and communication skills for remote collaboration.
• Ability to manage multiple projects simultaneously while meeting strict deadlines.