Senior Engineer, Sterile Drug Ops (Remote)

Mallinckrodt plc; United States; Remote; USD 80,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova is seeking a Senior Engineer, Commercial Technical Operations, to provide hands-on technical support for sterile drug product manufacturing across its external network. The role emphasizes aseptic filling, lyophilization, and CCIT, with travel to CMOs.

It’s a hybrid/remote role based near Philadelphia, PA, with travel to sites in multiple states. The candidate brings 7+ years in sterile manufacturing, strong regulatory knowledge, and experience with CAPA, process validation, and

Qualifications

• Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or related field.
• Minimum 7 years in sterile drug product manufacturing in a cGMP environment.
• Experience supporting aseptic filling for vials and/or prefilled syringes.

Responsibilities

• Provide direct technical oversight for commercial sterile drug product manufacture at CMOs.
• Support aseptic filling operations for injectable presentations and manufacturing readiness.
• Lead investigations, CAPA development, root-cause analysis and change control.
• Develop and improve contamination control strategies with cross-functional teams.
• Support technology transfer, validation, and continued process verification for sterile products.

Skills

Aseptic processing

Lean Six Sigma

Regulatory compliance

Technical communication

Education

Bachelor’s degree in pharmaceutical sciences or engineering

Tools

Quality systems

Job description

Keenova is seeking a Senior Engineer, Commercial Technical Operations, to provide hands-on technical support for sterile drug product manufacturing across its external network. The role emphasizes aseptic filling, lyophilization, and CCIT, with travel to CMOs.

It’s a hybrid/remote role based near Philadelphia, PA, with travel to sites in multiple states. The candidate brings 7+ years in sterile manufacturing, strong regulatory knowledge, and experience with CAPA, process validation, and