Manufacturing Engineer I: cGMP Process Transfer

Vitalbio; Oakville; On-site; CAD 80,000 - 95,000; Full time

Job summary

Vital Bio in Oakville, Ontario is seeking a Manufacturing Engineer to lead tech transfer from R&D into GMP manufacturing, designing scalable assembly processes for prototypes through production.

You will develop process flow maps, validate equipment, and drive continuous improvement, working with Engineering, Assay Development, and Quality to ensure high quality and cost-effective production.

Qualifications

• Bachelor’s degree in STEM required.
• 5+ years of manufacturing engineering and/or operational experience in Diagnostics or similar industries.
• Familiarity with IVD manufacturing, validation/qualification and cGMP processes.
• Strong communication and attention to detail.
• Ability to lead cross-functional teams and multitask.

Responsibilities

• Execute the transfer of manufacturing processes into a cGMP environment.
• Design manufacturing processes and conduct process development activities.
• Lead risk assessments and develop mitigation strategies for tech transfer.
• Interface with Engineering to define manufacturing and inventory controls.
• Support assay development and engineering to supply prototype assemblies.
• Establish processes to maintain quality from prototype to production.
• Lead validation activities for equipment, facilities, and processes.
• Identify, procure and maintain critical manufacturing equipment.
• Create and maintain cGMP documentation and SOPs.

Skills

Critical thinking

Analytical reasoning

Communication

Organization

Collaboration

Problem solving

Education

Bachelor's degree in STEM

Job description

Vital Bio in Oakville, Ontario is seeking a Manufacturing Engineer to lead tech transfer from R&D into GMP manufacturing, designing scalable assembly processes for prototypes through production.

You will develop process flow maps, validate equipment, and drive continuous improvement, working with Engineering, Assay Development, and Quality to ensure high quality and cost-effective production.