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Scientific Search · 6 hours ago

Process Engineer III/Senior

Washington, United States

Full-time

Onsite

Mid, Senior Level

3+ years exp

Scientific Search is a global CDMO that provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Process Engineer III/Senior will be responsible for managing pharmaceutical processes, technical transfers, and optimizing manufacturing processes to enhance efficiency and quality.

Human ResourcesStaffing Agency

Growth Opportunities

Responsibilities

Provide ownership and focus for pharmaceutical processes and technical transfers

Engage in and manage projects and multi-disciplinary teams with direct supervision

Contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees

Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability

Oversee and assess existing processes and workflows

Establish and track process metrics to monitor process stability and discover areas for improvement

Technical Transfer of new products from both internal and external clients

Ownership of product process from initial quote to product retirement

Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing

Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product

Develop and execute validation studies to test and qualify new and improved manufacturing processes

Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support

Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes

Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted

Participate in or perform deviation investigation and evaluation of impact

Implement effective CAPAs

Responsible for optimizing gross profit margin and minimizing deviation rate

Provide necessary reviews for regulatory and client audits and provide responses to audit observations

In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control

Qualification

Pharmaceutical experienceStatistical AnalysisLean Manufacturing PrinciplesProject ManagementSupervisory ExperienceTechnical TransferCGMP knowledgeTroubleshootingData analysisCommunication skills