- Expiry Date: 04 June 2022
- Referral: email@example.com
The Engineer in the Process Monitoring and Analytics (PMA) group within Manufacturing Sciences & Technology will be responsible for product robustness for the commercial biologics portfolio manufactured and third party manufacturing sites.
The PMA team, is also located at various locations and is responsible for leading and reporting product robustness for biologics drug substance and drug product manufacturing.
The group also provides advanced data analysis and implementation and maintenance of effective Statistical Process Control (SPC) programs across the biologics network at (internal and Third Party Manufacturing sites).
The candidate will interact with the different parts of the Biologics Development organization, and all Biologics Manufacturing sites.
Provides support to maintain the product/site Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
Manage and support investigations as a result of robustness events and SPC trending.
Provides system administration/maintenance of the Discoverant system.
Manage and support data inquiries from regulatory agencies and matrix teams using data systems (LIMS, Discoverant, Datalake).
Provides data and analysis for regulatory inspections and other interactions with regulatory agencies as required.
Demonstrates a strong knowledge of cGMP compliance, regulatory agency requirements and procedures and incorporate into all assigned projects.
Manages the implementation of process or equipment changes as a result of the SPC program.
Support the MS&T book of work including experimental design, statistical training and advanced analysis of complex datasets to support next generation process development, technical transfers and process improvements.
Support the development of dashboards and automated reporting capabilities for process and product robustness.
Provide statistical analysis on complex datasets using statistical packages (JMP, Minitab) and/or coding (R/Python).
Partner with laboratory groups and MT to build capability using new technologies (e.g Umetrics, and PAT) to gather and analyze process data to drive yield improvements and process robustness.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.