Senior Engineer, Commercial Technical Operations

Mallinckrodt Pharmaceuticals

. Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at contract manufacturing organizations .

Posted 10/13/2026full-timeUnited StatesSenior💰 $80,000 - $129,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in sterile drug product manufacturing, including aseptic filling operations, lyophilization, and terminal sterilization processes. Proficient in regulatory compliance, technical oversight, and process improvement methodologies such as Lean and Six Sigma.

Highest-signal resume keywords

Sterile Drug Product ManufacturingAseptic Filling OperationsLyophilizationLean Six Sigma MethodologiesCGMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aseptic TechniqueContamination ControlEnvironmental MonitoringTechnical InvestigationsRisk ManagementProcess ValidationChange ControlTechnical AssessmentsBatch Record ChangesManufacturing Process Improvements

Soft Skills

Excellent Communication SkillsTechnical JudgmentCollaborationInfluencing SkillsIndependent Work

Tools & Technologies

CCITCombination ProductsSelf-Injectable DevicesSOPsTechnical Agreements

Industry Keywords

CGMPEU GMP Annex 121 CFR 21021 CFR 211Pharmaceutical SciencesBiotechnology

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at contract manufacturing organizations
Support aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review
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 corrective-action implementation
Develop, maintain, and improve contamination control strategies with Quality, Manufacturing, Microbiology, Engineering, and CMO teams
Provide technical support for container closure systems, CCIT, combination products, self-injectable devices, packaging, and device assembly
Support technology transfer, process validation, continued process verification, process capability assessment, and manufacturing process improvements
Author, review, or approve technical assessments, protocols, reports, investigation summaries, risk assessments, SOPs, batch record changes, technical agreements, and CMO governance materials
Apply Lean and Six Sigma tools to improve process robustness, compliance, throughput, right-first-time performance, and cost effectiveness
Build relationships with external manufacturing partners and internal stakeholders, communicate technical risks, and escalate issues affecting quality, compliance, supply, or patient use
Maintain current knowledge of sterile manufacturing regulatory and industry expectations and translate them into practical controls and improvements
Report to the Director, Commercial Technical Operations; provide technical leadership across matrix teams and serve as a key technical contact for CMO teams

Requirements

What you’ll need

Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline required
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
Working knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, sterilization, and EU GMP Annex 1 required
Working knowledge of 21 CFR 210 & 211 and applicable USP guidance required
Experience with lyophilization, terminal sterilization, CCIT, manual visual inspection, combination products, or self-injectable device assembly strongly preferred
Experience supporting external or contract manufacturing sites, technology transfer, validation, continued process verification, investigations, CAPA, and change control preferred
Working knowledge of risk-management and structured problem-solving tools, with demonstrated use of Lean and/or Six Sigma methods required
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

Benefits

Comp & perks

Competitive pay and benefits
Bonus eligibility in accordance with the applicable program