Sr Process Engineer

MBR & Associates; New Jersey; On-site; USD 90,000 - 115,000; Full time

Job summary

A pharmaceutical company in New Jersey is seeking a Sr Process Engineer to lead continuous process improvement initiatives. Candidates should have a minimum of 5 years of experience in process development and possess a Bachelor’s Degree in Engineering or Sciences. The role includes applying Six Sigma principles and statistical analysis to enhance manufacturing processes. This position promises opportunities for impactful contributions to compliance and quality metrics.

Qualifications

• Minimum of 5 years experience in Process Development, Process Improvement or Manufacturing within the pharmaceutical industry.
• Expertise in troubleshooting or developing various unit operations is beneficial.

Responsibilities

• Apply solid oral dose theory and Six Sigma principles to process improvement.
• Completion of Annual Product Reviews with Statistical Process Control.
• Support process related deviation resolution.

Skills

Statistical analyses using MS Excel

Knowledge of unit operations

Troubleshooting unit operations

Education

Bachelor’s Degree in Engineering or Sciences

Job description

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