Mallinckrodt Pharmaceuticals je globalno biofarmacevtsko podjetje, osredotočeno na razvoj in zagotavljanje zdravil za bolnike s kompleksnimi zdravstvenimi stanji. Njegov farmacevtski portfelj vključuje zdravljenja, povezana z obvladovanjem bolečine in avtoimunskimi boleznimi, pri čemer je njegovo delo usmerjeno v obravnavanje nezadovoljenih zdravstvenih potreb in podporo oskrbi bolnikov. Podjetje je bilo ustanovljeno leta 1867 ter deluje na področjih zdravstva, proizvodnje in farmacije.
Senior Engineer, Commercial Technical Operations
Oversee sterile drug manufacturing, aseptic filling, and process improvements across Keenova’s external manufacturing network. Support contract manufacturers with investigations, validation, compliance, and device assembly.
Opis
- Provide technical oversight and on-site support for commercial sterile drug manufacturing at contract manufacturing organizations.
- Support aseptic filling of injectable products, from manufacturing readiness and batch execution through monitoring, troubleshooting, and post-batch review.
- Support lyophilization and terminal sterilization, including cycle execution, performance monitoring, technical assessment, and lifecycle improvements.
- Lead or assist technical investigations, deviations, CAPA development, root-cause analysis, change control, and corrective actions.
- Work with Quality, Manufacturing, Microbiology, Engineering, and contract manufacturers to develop and improve contamination control strategies.
- Support container closure systems, CCIT, combination products, self-injectable devices, packaging, and device assembly.
- Support technology transfer, process validation, continued process verification, capability assessments, and manufacturing improvements.
- Prepare, review, or approve technical assessments, protocols, reports, investigation summaries, risk assessments, SOPs, batch record changes, technical agreements, and contract manufacturer governance materials.
- Use Lean and Six Sigma methods to improve process robustness, compliance, throughput, right-first-time performance, and cost effectiveness.
- Build relationships with manufacturing partners and internal stakeholders; communicate technical risks and escalate issues affecting quality, compliance, supply, or patient use.
- Keep current with sterile manufacturing regulations and industry expectations, translating them into practical controls and improvements.
- Report to the Director of Commercial Technical Operations, lead technically across matrix teams, and serve as a key technical contact for contract manufacturers.
Zahteve
- Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical field.
- At least seven years of hands-on sterile drug product manufacturing experience in a cGMP-regulated pharmaceutical or biopharmaceutical setting.
- 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 21 CFR 210 and 211 and applicable USP guidance.
- Strongly preferred: experience with lyophilization, terminal sterilization, CCIT, manual visual inspection, combination products, or self-injectable device assembly.
- Preferred experience supporting external or contract manufacturing sites, technology transfer, validation, continued process verification, investigations, CAPA, and change control.
- 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 turn findings into clear, executable actions.
- Strong written and verbal communication, sound technical judgment, and the ability to influence and collaborate across matrix teams and with external partners.
- Ability to work independently in a remote setting, manage competing priorities, and travel regularly to contract manufacturing locations.
Ugodnosti
- Competitive pay and benefits.
- Bonus eligibility under the applicable program.