Sr Process Engineer
Responsible for applying solid oral dose theory, experience, and Six Sigma principles to continuous process improvement; completion of Annual Product Reviews inclusive of Statistical Process Control and practical manufacturing analysis in support of FDA/GMP requirements; Trend Analysis of deviation and complaint investigations, and associated corrective actions; the development and execution of continuous improvement projects; and maintenance of defined QA metrics; Identify product related CAPA plans (corrective / preventive actions); Support process related deviation resolution; Provide cross-functional support to other departments as necessary; Identify quality / compliance related issues; Maintain defined department / site metrics and report to senior management.
Minimum of 5 years experience in Process Development, Process Improvement or Manufacturing within the pharmaceutical industry. Bachelor’s Degree in Engineering or Sciences.
Expertise in troubleshooting or developing various unit operations is beneficial. The ideal candidate will be able to knowledgeably discuss unit operations and analytical methods, be capable of performing statistical analyses using MS Excel and Statistical Analysis Packages, and write compelling evaluations of those analyses.
Location: New Jersey