Senior Process Engineer

Workforce Genetics; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in biopharmaceutical manufacturing seeks a Senior Process Engineer to drive innovation and operational excellence. In this pivotal role, you will lead process improvements, ensuring compliance with FDA and GMP standards while collaborating cross-functionally with various teams. Your expertise in process simulation and cell culture will be crucial in shaping the future of cell therapy manufacturing. Join a forward-thinking company where your contributions will significantly impact groundbreaking advancements in the biopharma sector.

Qualifications

• 5+ years of experience in BioPharma Life Sciences.
• Hands-on GMP experience, including change controls and CAPAs.

Responsibilities

• Spearhead process optimization and lead CQV efforts for new equipment.
• Collaborate with senior leadership to align engineering strategies.

Skills

Process Optimization

CQV (Commissioning, Qualification & Validation)

GMP Compliance

Cell Culture Processes

Analytical Skills

Leadership Skills

Education

Degree in Chemical Engineering

Degree in Mechanical Engineering

Degree in Biochemical Engineering

Job description

Senior Process Engineer - Biopharma Manufacturing (Philadelphia, PA Area)

Are you ready to shape the future of biopharmaceutical manufacturing?

Workforce Genetics is seeking a Senior Process Engineer to drive innovation and operational excellence within a cutting-edge cGMP facility. This is an exciting opportunity to lead process improvements, support strategic growth, and influence groundbreaking advancements in cell therapy and biopharma manufacturing.

What You'll Do :

• Spearhead process optimization, ensuring the seamless integration of new equipment and technologies.
• Lead CQV (Commissioning, Qualification & Validation) efforts for state-of-the-art process equipment.
• Develop and refine technical transfer documents, supporting next-generation biopharma manufacturing.
• Collaborate with senior leadership to align process and facility engineering strategies with long-term growth objectives.
• Ensure compliance with FDA, EMA, and ISO regulations while upholding GMP excellence.
• Work cross-functionally with automation, facility design, and mechanical teams to drive innovation.

What You Bring :

• Degree in Chemical, Mechanical, or Biochemical Engineering (BS / MS)
• 5+ years of experience in BioPharma Life Sciences, with expertise in process simulation and safety reviews.
• Hands-on GMP experience, including change controls, deviation management, and CAPAs. Strong knowledge of cell culture processes and cell therapy manufacturing (preferred). Exceptional communication, analytical, and leadership skills to drive impactful results.