NPI Process Engineer – Hybrid Role (GMP)

PSC Biotech Ltd; Pomona (CA); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A leading biotech consultancy firm in Pomona seeks a Process Engineer to join their team. You will provide technical support for new product introductions and commercial manufacturing, ensuring compliance with GMP regulatory standards. Ideal candidates have a Bachelor's degree in a technical field and at least three years of related experience. This role offers opportunities in a dynamic environment with a focus on continuous improvement and technical excellence.

Qualifications

• Min 3 years of experience ideally in manufacturing, preferably GMP Setting.
• Demonstratable experience of leading technical related projects.
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes.
• Knowledge of sterile filling processes and equipment.

Responsibilities

• Design/Author/Review qualification/validation documentation.
• Technical input into quality notifications.
• Perform root cause analysis of system failures.
• Drive compliance of Global Policies and regulatory requirements.
• Work collaboratively to drive a safe and compliant culture.

Skills

Bachelor’s Degree or higher preferred

3 years experience in manufacturing

Experience leading technical projects

Knowledge of process monitoring systems

Knowledge of regulatory/code requirements

Equipment and process validation

Proficiency in Microsoft Office

Excellent communication skills

Education

Bachelor’s Degree in Science, Engineering or Technical discipline

Tools

DeltaV

Pi System

Job description

A leading biotech consultancy firm in Pomona seeks a Process Engineer to join their team. You will provide technical support for new product introductions and commercial manufacturing, ensuring compliance with GMP regulatory standards. Ideal candidates have a Bachelor's degree in a technical field and at least three years of related experience. This role offers opportunities in a dynamic environment with a focus on continuous improvement and technical excellence.