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-timeRemote • Pennsylvania • United StatesSenior💰 $80,000 - $129,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in sterile drug product manufacturing, aseptic processing, and regulatory compliance, with a strong focus on process improvement and technical oversight. Proficient in collaboration with cross-functional teams to enhance manufacturing operations and ensure adherence to industry standards.

Highest-signal resume keywords

Aseptic Filling OperationsSterile Drug Product ManufacturingLean and Six Sigma MethodsTechnical Investigations and CAPARegulatory Compliance (EU GMP, 21 CFR)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aseptic ProcessingLyophilizationTerminal SterilizationContamination ControlProcess ValidationTechnical AssessmentsRisk ManagementEnvironmental MonitoringContainer Closure Integrity TestingBatch Record Changes

Soft Skills

Excellent Communication SkillsTechnical JudgmentCollaborationInfluencing SkillsIndependent Work

Certifications & Qualifications

Green Belt or Higher Certification

Industry Keywords

CGMPPharmaceuticalBiopharmaceuticalQuality AssuranceCombination ProductsSelf-Injectable DevicesSOPsTechnical AgreementsChange ControlProcess Capability Assessment

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 vial and prefilled syringe presentations, including readiness, batch execution, process monitoring, troubleshooting, and post-batch review
Apply 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, monitoring, technical assessment, and lifecycle improvement
Lead or support technical investigations, deviations, CAPA development, root-cause analysis, change control, and corrective actions
Develop and improve contamination control strategies with Quality, Manufacturing, Microbiology, Engineering, and CMO teams
Provide technical support for container closure systems and container closure integrity testing
Support technology transfer, process validation, continued process verification, process capability assessment, and sterile manufacturing improvements
Support combination products and self-injectable devices, including packaging, device assembly, and related investigations and changes
Author, review, or approve technical assessments, protocols, reports, investigations, risk assessments, SOPs, batch record changes, technical agreements, and CMO governance materials
Apply Lean and Six Sigma methods to improve 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 knowledge of sterile manufacturing regulatory and industry expectations and translate them into practical controls and improvements
Report to the Director, Commercial Technical Operations
Serve as a technical contact for CMO manufacturing, quality, engineering, validation, microbiology, packaging, and project teams

Requirements

What you’ll need

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 expectations required
Working knowledge of 21 CFR 210 & 211 and applicable USP guidance required
Knowledge of 21 CFR Part 4 & 820 an advantage
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
Experience in parenteral product packaging and assembly operations preferred
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 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