This position is for a Snr. Associate Tech. Engineering, reporting to the Process Monitoring & Data Analytics Team Lead within the Process Development (PD) group at ADL.
The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, and problem-solving techniques. The candidate will also have experience in the equipment function and data collection associated with vial and syringe filling lines for biological drug product manufacture.
Responsibilities include:
The candidate would typically be responsible for the following activities.
Core Responsibilities:
Trend rule analyses and investigations for in-process data trends.
Monthly data reporting for each product within scope of the process monitoring program to network product leads.
Working in a collaborative manner within cross functional teams supporting investigations, non-conformances, and CAPA closures associated with process monitoring trends analyses.
Executing automated as well as some manual trend analyses to support product reviews.
Updating database mapping revisions and product details to maintain automated analysis reporting capabilities for vial and syringe drug products manufactured at ADL.
Performing initial configuration and ongoing maintenance of validated automated Spotfire reports to enable ongoing compliance with reporting requirements.
Supporting the calculation and documentation of control limits.
Delivering process monitoring summaries for Annual Product Reviews.
Drafting updates to site process monitoring plans and SOPs.
Additional Responsibilities
Support the extension of data analysis tools and expertise within PD and other departments at ADL.
Support network initiatives in new applications and advanced data analysis techniques at ADL.
Basic Qualifications:
Bachelors or Masters degree in Science, Engineering, data science or data analytics.
2+ years experience in manufacturing environment (biotechnology, pharmaceutical, medical device or high volume manufacturing) using process data and statistical analysis to drive decision making (e.g. SPC trending, Nelson/WACO trend rules, process capability, etc)
Preferred Experience
GMP experience including regulatory agency audits
Proficiency in the basic operation and automation configuration associated with vial and syringe filling production lines
Familiarity with biological drug product manufacturing and Inspection processes
Experience using the following applications:
Statistical analysis tools (JMP, Minitab, SAS, R)
Visual analysis tools (Spotfire, Cognos, SAP BO, Tableau)
Accessing data from manufacturing systems (Werum PAS-X, PI, SM LIMS)
Using SQL to create custom queries from databases and then integrating with visual analysis tools
Lean 6-Sigma training
GCF Level
GCF Level 04
Career Category
Process Development
Position Type
Full time
