Process Engineer

United Pharma; New York (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading biopharma company in New York is seeking an experienced Process Engineer. This role focuses on supporting formulation and filling operations, driving process improvements, and managing CAPA and change control protocols. The ideal candidate should have over 5 years of experience in the Pharma/Biotech sector, strong knowledge of GMP, and a solid background in process engineering activities. Join a dynamic team dedicated to high-quality biopharma manufacturing.

Qualifications

• 5+ years of Process Engineering experience in Pharma or Biotech.
• Strong knowledge of GMP, CAPA, and Change Controls.
• Experience in formulation, filling, or lyophilization.

Responsibilities

• Act as CAPA and Change Control point of contact.
• Perform root cause analysis and process improvement activities.
• Author protocols, reports, and GMP documentation.
• Work closely with Manufacturing, QA, and Validation teams.
• Support inspections and compliance activities.

Skills

Process Engineering experience in Pharma/Biotech

Formulation / Filling / Lyophilization

GMP knowledge

CAPA knowledge

Change Control knowledge

Quality systems or document management tools

Job description

We are looking for an experienced Process Engineer to support formulation and filling operations within a biopharma manufacturing environment. The role will focus on process improvement, CAPA ownership, and change control support.

What You Will Do

• Act as CAPA and Change Control point of contact
• Perform root cause analysis & process improvement activities
• Author protocols, reports, and GMP documentation
• Work closely with Manufacturing, QA, and Validation teams
• Support inspections and compliance activities

What We’re Looking For

• 5+ years of Process Engineering experience in Pharma/Biotech
• Experience in Formulation / Filling / Lyophilization
• Strong knowledge of GMP, CAPA, Change Controls
• Experience with quality systems or document management tools
• Manufacturing, quality, or validation background is a plus