Senior Biotech Process Engineer — Contract

ProQuality Network; Northern (KY); Hybrid; USD 100,000 - 150,000; Full time

Job summary

ProQuality Network has contracted a Senior Engineer to lead process optimization initiatives in a highly regulated biotechnology manufacturing environment. The role requires hands-on problem solving and the ability to collaborate with operations, quality, validation, facilities, and capital projects teams.

The ideal candidate will bring advanced engineering expertise, strong cGMP experience, and a track record of managing complex projects from concept through execution.

Qualifications

• Advanced engineering degree with relevant biotech/pharma background.
• Experience with cGMP procedures and validation practices.
• Experience with change control and CAPA processes.

Responsibilities

• Execute complex or novel assignments requiring new or improved engineering techniques.
• Develop engineering policies impacting multiple units.
• Supervise and review work of engineers and technicians.
• Apply advanced engineering methodologies within area of expertise.
• Serve as a technical specialist in at least one discipline.
• Plan and conduct projects with mature engineering judgment.
• Support additional engineering functions as assigned.
• Develop technical solutions to complex challenges.
• Partner with cross-functional teams to define requirements for large-scale modifications.
• Collaborate with project managers to deliver projects within scope, schedule, budget, and quality.

Skills

Leadership

Project management

Cross-functional collaboration

Technical writing

Problem solving

Regulatory compliance

Operational troubleshooting

Education

Doctorate in Engineering

Master’s + 2 years relevant experience

Bachelor’s + 4 years relevant experience

Tools

Maximo

Job description

ProQuality Network has contracted a Senior Engineer to lead process optimization initiatives in a highly regulated biotechnology manufacturing environment. The role requires hands-on problem solving and the ability to collaborate with operations, quality, validation, facilities, and capital projects teams.

The ideal candidate will bring advanced engineering expertise, strong cGMP experience, and a track record of managing complex projects from concept through execution.