Tech Ops Scientist - Pilot Plant
Location: North America, United States, Pennsylvania, Lititz
Work Location: Fully Onsite
The Scientist supports Technical Operations R&D; Pilot Plant for a broad range of pilot scale consumer cosmetics, OTC drug products, and OTC monograph drug products.
GMP training
GDP
Identify, report, and seek correction for deviations noted in the workplace
Audit/compliance with procedures
Processes and project tasks per established timeline
Production of Pilot scale batches and Clinical Supplies operations
Batch requests in the pilot plant
Clinical Supplies Project Execution and Coordination including repacking and labeling operations for clinical supplies
Planned experimental design (i.e., sample collection, in-process testing, sample management, etc.)
Data analysis and summary
Change control deliverables/documentation, investigations, and corrective/preventive actions
Investigations related to product out of specification or process deviation, stability deviation, consumer complaints, and other investigations as applicable
Laboratory experimentation as needed related to investigations and root cause analysis
Troubleshooting of scale-up issues, root cause analysis, and remediation for technical-related issues
CAPA implementation and follow up
Manufacturing process improvements through data analysis, identification of critical process parameters, DOE to determine best processes
Writing technical documentation including but not limited to Manufacturing Work Instructions, Fill Records, Cleaning Procedures, Technical Justifications, and INV reports
Mentorship to contractors
End to End Pilot Tasks including material management, cleaning and sanitization of small-scale equipment, labeling, shipping, document control/closure
May assist in process or equipment validation
Annual base salary for new hires in this position ranges: $72,675.00 - $102,600.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors