Senior Engineer, Commercial Technical Operations

Mallinckrodt Pharmaceuticals•Philadelphia, PA

2d•$80,000 - $129,000•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. This is a hybrid role based in the Philadelphia, Pennsylvania area, with regular travel to contract manufacturing sites, including but not limited to, locations in Washington State and Baltimore, Maryland.

Requirements

Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline required; advanced degree preferred.
Minimum of seven years of direct, hands-on experience in sterile drug product manufacturing within a cGMP-regulated pharmaceutical or biopharmaceutical environment required.
Demonstrated experience supporting aseptic filling operations for vials and/or prefilled syringes required; experience with both presentations preferred.
Working knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, sterilization. and EU GMP Annex 1 required.
Working knowledge of appropriate regulations including 21 CRF 210 & 211, applicable USP guidance’s, EU GMP Annex 1 required.
Knowledge of 21 CFR Part 4 & 820 an advantage.
Working knowledge of risk-management and structured problem-solving tools, with demonstrated use of Lean and/or Six Sigma methods required; Green Belt or higher certification preferred.
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 the 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

Experience with one or more of the following is strongly preferred: 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 preferred.
Experience in parenteral product packaging and assembly operations preferred.

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 associated 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.
Provide technical input to batch records, standard operating procedures, protocols, reports, risk assessments, technical agreements, and CMO governance materials.
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.