Pharma Process Engineer: Tech Transfer & Scale‑Up Lead

Bimeda; Pomona (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Insurance (medical, dental, and

401(k) plan

Paid time off (vacation, sick leave, H

Life insurance

Employee assistance program

Job summary

Bimeda in Pomona, CA, seeks a Process Engineer to drive technology transfer, scale-up, and validation of pharmaceutical manufacturing processes. You will collaborate with production, quality, validation, and engineering teams to ensure compliant, robust operations delivering high-quality products.

Responsibilities include developing transfer protocols, conducting validation, analyzing CPPs/CQAs, and leading risk mitigation and continuous improvement initiatives to support reliable commercial

Qualifications

• Bachelor's degree in Chemical Engineering with 4+ years of relevant experience in process engineering, process design, technology transfer, or validation within pharmaceutical manufacturing.
• Master's degree in Engineering or a related discipline with 2+ years of relevant experience.
• Experience in pharmaceutical manufacturing, preferably within a GMP-regulated environment.
• Experience with technology transfer, process design, scale-up, process validation, and continuous process improvement.

Responsibilities

• Lead and execute technology transfer activities for commercial pharmaceutical products, including development of technology transfer protocols, reports, engineering batch protocols, and equipment compatibility assessments.
• Coordinate pilot, engineering, and validation batches with production, quality, validation, engineering, and other cross‑functional teams.
• Develop and refine process flow diagrams, compounding instructions, and other technical documentation required to support commercial manufacturing.
• Apply process understanding and QbD principles to ensure processes are scalable, reproducible, and capable of consistently meeting quality and manufacturing requirements.
• Monitor process performance during scale‑up and transfer activities and identify and resolve technical issues and process risks.
• Develop and execute process validation protocols and reports and support ongoing process verification activities.
• Evaluate CPPs, CQAs, and process performance data to assess process capability, robustness, and variability.
• Conduct or support laboratory, pilot, engineering, and validation batches to generate process knowledge and support regulatory requirements.
• Use statistical analysis, process monitoring, and trending to identify emerging risks and opportunities to improve process control and performance.
• Design and optimize manufacturing processes using sound chemical engineering principles and QbD methodology.
• Conduct process risk assessments, including FMEA, and develop risk mitigation strategies.
• Provide technical leadership for deviations, OOS investigations, root cause analysis, CAPAs, and Change Controls.
• Review production batch records and manufacturing documentation to ensure alignment with approved process design and technical requirements.
• Ensure process activities and recommendations comply with GMP and regulatory requirements.
• Identify opportunities to improve process robustness, manufacturing efficiency, product quality, yield, and reliability.
• Support the selection, acquisition, qualification, and implementation of new production equipment and technologies.
• Lead or support equipment and process improvement initiatives, including a new transfer pump project.
• Use data and structured problem solving to reduce variability and waste.

Skills

Technology transfer

Process scale-up

QbD

Statistical analysis

Cross-functional leadership

Education

Bachelor's degree in Chemical Engineering

Master's degree in Engineering or related

Tools

Mixing tanks

Filling lines

Autoclaves

Job description

Bimeda in Pomona, CA, seeks a Process Engineer to drive technology transfer, scale-up, and validation of pharmaceutical manufacturing processes. You will collaborate with production, quality, validation, and engineering teams to ensure compliant, robust operations delivering high-quality products.

Responsibilities include developing transfer protocols, conducting validation, analyzing CPPs/CQAs, and leading risk mitigation and continuous improvement initiatives to support reliable commercial