Our client, a leading pharmaceutical company, is hiring a Process Engineer on a contract basis.
50% onsite 50% remote
Work Location: SMW, NJ or Seattle, WA
1. Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations and when needed, provide on-site technical process support of ongoing manufacturing processes.
2. Create and revise technical documentation (e.g. changes controls, SOPs, and batch records)
3. Perform deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.
4. Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control
5. Collaborate with cross-functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing.
6. Performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.
7. Perform detailed review of Process Development processes and generate technology transfer documents, including process monitoring (manufacturing data analysis, summary, and presentation) and authoring campaign summary reports.
8. Develop simulated process models to estimate throughput capacity, resources and inventory levels.
OpEx and Lean Six Sigma project experience is strongly preferred
Extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.
Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization.
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
Experience or knowledge of creating computer-based process models using process simulation software.
Experience or knowledge of statistical analysis using statistical software package.
Able to creatively manage time and elevate relevant issues to project lead and line management.
Strong scientific and technical writing.
Detail oriented with excellent verbal and written communication skills.
Ability to travel domestically and internationally.
Qualifications & Experience
MSc or BSc in Biology, Chemical Engineering, Biochemical Engineering or equivalent with 5+ years of relevant experience in process development or commercial manufacturing.
Knowledge of CAR-T and/or lentiviral vector manufacturing a plus.