Senior Process Engineering Lead - Drug Substance & Product

BeOne Medicines; Hopewell (NJ); On-site; USD 139,000 - 184,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Paid Time Off

Wellness

Job summary

BeOne Medicines seeks a Senior Manager of Process Engineering for Dug Substance and Drug Product at the Hopewell, NJ site. Lead a hands-on team to support tech transfers, equipment selection, and day-to-day manufacturing.

You will drive deviation investigations, regulatory inspections support, and continuous improvement, working with Operations, Quality, and Automation to ensure right-first-time quality. Requires 7+ years GMP pharma operations experience and a BS in engineering; travel up to 5%

Qualifications

• Minimum 7 years of GMP pharma operations support.
• Experience leading technical teams and managing complex priorities.
• Proven ability in technology transfer and equipment qualification.
• Strong analytical problem-solving and proactive decision-making.
• Proficient in MS Office and project management tools.

Responsibilities

• Lead technical teams with a focus on right-first time quality.
• Oversee design, selection, and troubleshooting of systems and equipment for Drug Substance and Drug Product manufacturing.
• Support technology transfer and qualification studies for processes, systems, and facilities.
• Partner with Operations, Quality, and Automation to ensure compliance and execution.
• Develop and review technical documentation and lead fault analysis remediation.
• Support operations with troubleshooting and issue resolution; travel up to 5%.

Skills

Leadership

GMP

Project management

Biopharma

Analytical thinking

Education

BS in engineering

Tools

Microsoft Project

AutoCAD

Smartsheet

SharePoint

Power BI

Excel

Job description

BeOne Medicines seeks a Senior Manager of Process Engineering for Dug Substance and Drug Product at the Hopewell, NJ site. Lead a hands-on team to support tech transfers, equipment selection, and day-to-day manufacturing.

You will drive deviation investigations, regulatory inspections support, and continuous improvement, working with Operations, Quality, and Automation to ensure right-first-time quality. Requires 7+ years GMP pharma operations experience and a BS in engineering; travel up to 5%