Engineer III, Validation - Process & Cleaning
Core
Lead validation activities for process and cleaning in sterile pharmaceutical manufacturing environments to ensure compliance and quality.
Role type
Senior IC validation engineer (process & cleaning)
Builds
Sterile pharmaceutical products and validated manufacturing processes
Domain
Pharmaceutical manufacturing / Biotech / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Cleaning validation, Equipment qualification (IQ/OQ/PQ), Protocol writing, Deviation investigation, Regulatory standards knowledge, Audit participation
Preferred skills
Sterile/aseptic filling experience, Sterile processing operations, FDA/EMA/cGMP regulations expertise
Technologies
None stated
Responsibilities
Lead process validation and cleaning validation activities, Execute equipment qualification (IQ/OQ/PQ), Support tech transfers and new product introductions, Investigate deviations and write reports, Participate in audits and regulatory readiness
Seniority
Senior, hands-on IC
