Senior Engineer, Commercial Technical Operations

Mallinckrodt Pharmaceuticals • Philadelphia, PA

10d • Remote

About The Position

The Senior Engineer, Commercial Technical Operations provides hands-on technical support and oversight for sterile drug product manufacturing across Keenova’s external manufacturing network. The role applies direct manufacturing experience in aseptic filling of vial and prefilled syringe presentations, with additional expertise in lyophilization, terminal sterilization, contamination control, and container closure integrity. The specialist serves as a practical interface between Keenova and contract manufacturing partners, supporting reliable supply, compliant execution, investigations, process and lifecycle improvements, packaging, and combination product assembly.

The position is based in the Philadelphia, Pennsylvania area and involves regular travel to contract manufacturing sites, including locations in Washington State and Baltimore, Maryland. The role is an individual contributor reporting to the Director, Commercial Technical Operations, with no direct reports unless otherwise assigned. It works closely with internal cross-functional teams and serves as a key technical contact for external manufacturing partners.

Requirements

• Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline.
• At least seven years of direct, hands-on experience in sterile drug product manufacturing within a cGMP-regulated pharmaceutical or biopharmaceutical environment.
• Demonstrated experience supporting aseptic filling operations for vials and/or prefilled syringes.
• Working knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, sterilization, and EU GMP Annex 1.
• Working knowledge of applicable regulations, including 21 CFR 210 and 211, applicable USP guidance, and EU GMP Annex 1.
• Working knowledge of risk-management and structured problem-solving tools, with demonstrated use of Lean and/or Six Sigma methods.
• Ability to interpret manufacturing data, identify process trends, assess technical risk, and convert findings into clear, executable actions.
• Excellent written and verbal communication skills, sound technical judgment, and ability to influence and collaborate across a matrix organization and with external partners.
• Ability to work independently in a remote environment, manage multiple priorities, and travel regularly to CMO locations.

Nice To Haves

• An advanced degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline.
• Experience supporting both vial and prefilled syringe presentations.
• Experience with lyophilization, terminal sterilization, CCIT, manual visual inspection, combination products, or self-injectable device assembly.
• Experience supporting external or contract manufacturing sites, technology transfer, validation, continued process verification, investigations, CAPA, and change control.
• Experience in parenteral product packaging and assembly operations.
• Knowledge of 21 CFR Part 4 and Part 820.
• Green Belt or higher certification in Lean or Six Sigma.

Responsibilities

• Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at contract manufacturing organizations (CMOs).
• Support aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review.
• Apply subject matter expertise in aseptic processing, cleanroom behavior, environmental and process controls, and EU GMP Annex 1 expectations.
• Support lyophilization and terminal sterilization processes, including cycle execution, performance monitoring, technical assessment, and lifecycle improvement.
• Lead or support technical investigations, deviation and CAPA development, root-cause analysis, change control, and implementation of sustainable corrective actions.
• Develop, maintain, and improve contamination control strategies in partnership with Quality, Manufacturing, Microbiology, Engineering, and CMO teams.
• Provide technical support for container closure systems and container closure integrity testing (CCIT), including assessment of manufacturing or component changes and investigation of integrity-related issues.
• Support technology transfer, process validation, continued process verification, process capability assessment, and manufacturing process improvements for sterile drug products.
• Provide technical support for combination products and self-injectable devices, including drug-device interface considerations, secondary or parenteral product packaging, device assembly, and related manufacturing investigations and changes.
• Author, review, or approve technical assessments, protocols, reports, investigation summaries, risk assessments, standard operating procedures, batch record changes, technical agreements, and CMO governance materials.
• Apply operational excellence methods, including Lean and Six Sigma tools, to improve process robustness, compliance, throughput, right-first-time performance, and cost effectiveness.
• Build effective working relationships with external manufacturing partners and internal stakeholders, communicate technical risks clearly, and escalate issues that may affect quality, compliance, supply, or patient use.
• Maintain current knowledge of relevant regulatory and industry expectations for sterile manufacturing and translate those expectations into practical manufacturing controls and improvements.
• Support routine site engagement and governance, coordinate resolution of manufacturing issues, and help ensure agreed technical actions are implemented effectively.

Benefits

• Competitive pay and benefits as part of a Total Rewards package.
• Eligible for a bonus in accordance with the terms of the applicable program; bonuses are awarded at the Company’s discretion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior