Senior Engineer, Commercial Tech Ops — Hybrid (Travel)

Keenova Therapeutics plc; United States; Hybride; USD 80 000 - 129 000; Plein temps

Résumé du poste

Keenova Therapeutics plc seeks a Senior Engineer, Commercial Technical Operations to provide hands-on technical support for sterile drug product manufacturing across Keenova’s external network. The role focuses on aseptic filling, lyophilization, and container closure integrity, interfacing with CMOs for reliable supply and compliant execution.

This hybrid role in Philadelphia includes travel to CMOs and requires governance of investigations, CAPAs, change control, and process improvements while

Qualifications

• Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or related field.
• 7+ years direct hands-on sterile drug product manufacturing in a cGMP environment.
• Experience supporting aseptic filling for vials and/or prefilled syringes.
• Knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring.
• Knowledge of 21 CFR 210/211, USP guidance, EU GMP Annex 1.
• Lean Six Sigma (Green Belt or higher) preferred.
• Experience with external manufacturing sites, tech transfer, validation, CAPA, change control.
• Parenteral packaging and assembly experience preferred.
• Ability to travel to CMOs.

Responsabilités

• Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at CMOs.
• Support aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review.
• Apply SME in aseptic processing, cleanroom behavior, environmental controls, and EU GMP Annex 1 expectations.
• Support lyophilization and terminal sterilization processes, including cycle execution and lifecycle improvement.
• Lead or support technical investigations, deviation and CAPA development, root-cause analysis, and change control.
• Develop and improve contamination control strategies with QA, Manufacturing, Microbiology, Engineering, and CMOs.
• Provide technical support for container closure systems and CCIT, including assessments and investigations.
• Support technology transfer, process validation, CPP, and manufacturing process improvements for sterile products.
• Provide technical input for drug-device interfaces, packaging, and device assembly.
• Author/review/approve technical docs and governance materials.
• Apply Lean/Six Sigma to improve robustness, throughput, and cost effectiveness.
• Provide input to batch records and SOPs, risk assessments, and CMO governance materials.
• Build relationships with external partners and internal stakeholders; communicate risks clearly.
• Maintain knowledge of regulatory expectations for sterile manufacturing and translate into controls.

Connaissances

Aseptic filling

Lyophilization

Terminal sterilization

Contamination control

CCIT

Process validation

CAPA investigations

Technology transfer

Lean Six Sigma

Regulatory knowledge

CMO collaboration

Formation

Bachelor’s degree in pharmaceutical sciences/engineering/biotechnology

Description du poste

Keenova Therapeutics plc seeks a Senior Engineer, Commercial Technical Operations to provide hands-on technical support for sterile drug product manufacturing across Keenova’s external network. The role focuses on aseptic filling, lyophilization, and container closure integrity, interfacing with CMOs for reliable supply and compliant execution.

This hybrid role in Philadelphia includes travel to CMOs and requires governance of investigations, CAPAs, change control, and process improvements while