Senior Engineer, Commercial Technical Operations

Job not on LinkedIn

🔥 4 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $80k - $129k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Mallinckrodt Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1867

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Mallinckrodt Pharmaceuticals is a global biopharmaceutical company that specializes in developing and delivering innovative therapies for patients with complex conditions. The company is committed to addressing unmet medical needs and improving patient care through its range of pharmaceutical products, including treatments for pain management, autoimmune disorders, and more.

📋 Description

• 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

• 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

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