Process Plant and CQ Lead

Role Summary

Process Plant and CQ Lead responsible for the engineering quality review and execution support for commissioning and qualification (C&Q) across projects, with emphasis on temperature mapping program management in antigen manufacturing.

Responsibilities

• Primary C&Q interface with project management and project controls for budget and schedule performance measurements and reporting
• Review and approval of protocols/test scripts, data packs and reports
• Audit engineering quality according to site and project level C&Q plans, GEGs and QOQGs
• Update and approve site C&Q platform methods and procedures
• Assist technical engineering staff with the engineering change management process
• Execute initiatives from internal and external audits, change control and deviation remediation
• May manage contract associates to support C&Q activities
• Review and approve engineering impact assessments, protocols and reports; apply global (GEG) and local engineering methods
• Execute System and Functional Component Criticality Assessments
• Execute Design Review and Qualification
• Author Protocol/Test Script and Reports as assigned
• Perform Periodic Reviews
• Strong foundation in Commissioning and Qualification

Qualifications

• Bachelor's Degree required
• 1-5 years of industry experience; biotech and pharmaceutical experience preferred
• Familiarity with IoT, digital twins, and smart manufacturing technologies
• Understanding of AI applications in predictive maintenance and asset management
• Ability to lead change management and support digital transformation initiatives
• Digital mindset and soft skills
• Agility in adopting and applying new technologies
• Data-driven problem-solving and decision-making
• Collaborative approach using digital platforms
• Innovation mindset and continuous learning
• Strong communication and data storytelling skills

Skills

• PowerBI, RPA, real-time analytics (preferred)
• Experience as SME in Commissioning and Qualification (preferred)
• Digital reliability or automation project experience (preferred)
• Proven ability to leverage technology to improve equipment uptime and efficiency (preferred)

Education

• Bachelor's Degree (required)