Associate I, Manufacturing Science & Technology Engineering
Core
Validation and qualification activities for highly regulated aseptic manufacturing facilities, ensuring processes remain compliant and in a validated state.
Role type
Associate I, Manufacturing Science & Technology Engineering (Validation)
Builds
Aseptic manufacturing processes and equipment for eye care products
Domain
Pharmaceutical manufacturing / GMP-regulated industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, statistical analysis, Quality Risk Analysis (QRA), change control management, data trending, technical transfer, aseptic manufacturing knowledge, sterilization knowledge
Preferred skills
None stated
Technologies
None stated
Responsibilities
Conduct ongoing process verification (OPV), statistical analysis, and data trending to monitor product quality and manufacturing performance. Develop and maintain Quality Risk Analyses (QRA). Identify process deviations, quality risks, and improvement opportunities through data-driven analysis. Support continuous process optimization and ensure products remain in a validated state of control. Prepare manufacturing process transfer documentation and manage change controls. Execute and support process validation, revalidation, and continuous improvement activities. Coordinate cross-functional validation activities. Manage and support change control processes. Drive process optimization and technical improvement initiatives.
Seniority
Associate I, 3+ years experience
