Senior Process Engineer
Core
Senior Process Engineer supporting manufacturing operations, technology transfer, and continuous improvement in pharmaceutical production.
Role type
Senior IC process engineer (pharmaceutical manufacturing)
Builds
Pharmaceutical products (APIs, finished dosage forms) for global patient access
Domain
Healthcare / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
technical risk assessment, quality by design (QbD), experimental design, technical data analysis, scientific writing, technology transfer, process performance qualification (PPQ), investigation and CAPA implementation, cleaning validation, new product introduction, product transfer, alternate source qualification, continuous process verification
Preferred skills
aseptic filling machine operation, pharmaceutical compounding, single use systems
Technologies
aseptic filling machines, single use systems
Responsibilities
Support manufacturing with technical expertise and change management; design experiments using QbD principles to investigate deviations; analyze technical data methodically; write scientific protocols and reports; develop innovative solutions for complex problems; participate in manufacturing quality investigations; support new product introduction, product transfers, and alternate source qualifications; support continuous process verification; assume responsibility for technology transfer projects; plan and execute PPQ batches; plan and execute product lifecycle projects; prepare cleaning validation documentation; coordinate manufacturing investigations; coach team members
Seniority
Senior, hands-on IC
