Remote Senior Engineer, Sterile Ops & CMO Partnerships

Mallinckrodt Pharmaceuticals; Philadelphia (Philadelphia County); Remote; USD 77,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Remote-friendly environment

Bonus program

Job summary

Keenova seeks an experienced Senior Engineer, Commercial Technical Operations to oversee sterile drug product manufacturing across CMOs. You will ensure aseptic filling quality, supervise lyophilization and sterilization processes, and drive lifecycle improvements while maintaining strong partner relations.

The role requires hands-on experience in aseptic processing, CAPA, risk assessment, and change control, with travel to CMOs. This is a hybrid/remote-ready position in the Philadelphia area.

Qualifications

• Bachelor's degree in pharmaceutical sciences, engineering or related field required; advanced degree preferred.
• Minimum of seven years of hands-on sterile drug product manufacturing experience in a cGMP environment.
• Experience supporting aseptic filling for vials and/or prefilled syringes required; both preferred.

Responsibilities

• Provide technical oversight and on-site support for sterile drug product manufacturing at CMOs.
• Support aseptic filling operations, including readiness, batch execution, monitoring and troubleshooting.
• Apply expertise in aseptic processing, cleanrooms, and EU GMP Annex 1 expectations.
• Lead or support investigations, CAPA, root-cause analysis, and change control.
• Develop contamination control strategies with Quality, Manufacturing and CMOs.
• Support technology transfer, validation, continued process verification, and process improvements.

Skills

Sterile manufacturing

LEAN & Six Sigma

Root-cause analysis

Regulatory knowledge

Education

Bachelor's degree in pharmaceutics/engineering

7+ years sterile drug product experience

Tools

None

Job description

Keenova seeks an experienced Senior Engineer, Commercial Technical Operations to oversee sterile drug product manufacturing across CMOs. You will ensure aseptic filling quality, supervise lyophilization and sterilization processes, and drive lifecycle improvements while maintaining strong partner relations.

The role requires hands-on experience in aseptic processing, CAPA, risk assessment, and change control, with travel to CMOs. This is a hybrid/remote-ready position in the Philadelphia area.