What are the responsibilities and job description for the Process Engineer position at Novozen Healthcare LLC?
Job Title: Process Engineer
Location : Buffalo, NY (Onsite)
Employment Type : Contract (W2)
Duration : 4 months
About the Role
We are seeking two Process Engineers to support pharmaceutical manufacturing operations in Buffalo, NY. This role will focus on process validation, quality compliance, investigations, and continuous improvement initiatives within a GMP-regulated environment.
Responsibilities
• Support process validation and manufacturing improvement activities
• Review and maintain Batch Manufacturing Records (BMRs)
• Conduct root cause investigations and implement corrective actions
• Support GMP audits and ensure compliance with quality standards
• Perform process trend analysis and statistical evaluations
• Apply risk assessment methodologies including FMEA and PFMEA
• Support Gage R&R studies and process capability assessments
• Collaborate with Quality, Manufacturing, and Engineering teams
Required Qualifications
• Bachelor’s degree in Engineering or related technical discipline
• Minimum 4 years of relevant pharmaceutical manufacturing experience
• Strong knowledge of GMP regulations and GMP audit support
• Experience with Design Controls, FMEA, and PFMEA
• Experience conducting Root Cause Analysis investigations
• Hands-on experience with Batch Manufacturing Records (BMRs)
• Knowledge of process trends, statistical analysis, and process validation
• Experience with Gage R&R studies and quality tools
• Strong communication and documentation skills
Preferred Qualifications (Optional)
• Experience in fast-paced pharmaceutical manufacturing environments
• Exposure to continuous improvement initiatives and CAPA activities
Salary
The hourly rate for this position is 30 -35 per hour ( DOE )
Benefits
This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check
Background checks may be conducted in accordance with applicable laws
Work Authorization
Applicants must be authorized to work in the United State
Salary : $30 - $35