Process Engineer - Lyophilization & Isolator Systems

Stark Pharma Solutions Inc; Lansdale (Montgomery County); On-site; USD 95,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks an experienced Process Engineer to support the startup and commissioning of a new GMP manufacturing facility in West Point, PA.

You will oversee lyophilization and isolator systems, coordinating with Engineering, CQV, and Operations to ensure equipment installation, startup, commissioning, and GMP readiness. The role requires hands-on lyophilization/aseptic processing experience, 5+ years in pharma/biotech engineering, and strong cross-functional collaboration

Qualifications

• Bachelor's degree in Engineering or related technical discipline required.
• Minimum 5 years of engineering experience in pharmaceutical or biotech manufacturing.
• Hands-on experience with lyophilization (freeze dryers), isolator systems, or aseptic processing equipment.
• Experience supporting GMP equipment startup, commissioning, and qualification activities.
• Familiarity with CQV (Commissioning, Qualification & Validation) processes.
• Experience supporting facility startups, equipment installation, and commissioning projects.
• Knowledge of sterile pharmaceutical manufacturing and GMP regulations.

Responsibilities

• Provide technical support for installation, startup, and commissioning of lyophilizers, isolators, and related aseptic process equipment.
• Collaborate with CQV teams to support commissioning, qualification, and equipment turnover activities.
• Coordinate with vendors, contractors, and cross-functional teams throughout project execution.
• Support Process Hazard Analyses (PHAs) and ensure equipment is implemented in accordance with GMP and site safety requirements.
• Troubleshoot equipment issues during startup and support operational readiness.
• Ensure compliance with GMP requirements throughout equipment startup and commissioning.
• Assist with engineering documentation and process improvement activities.

Skills

Lyophilization experience

Aseptic processing

Cross-functional collaboration

Troubleshooting

GMP compliance

Education

Bachelor's degree in Engineering

Tools

CQV processes

PHAs

Job description

Position: Process Engineer - Lyophilization & Isolator Systems
Location: West Point, PA
Duration: Long Term

Job Overview

We are seeking an experienced Process Engineer to support the startup and commissioning of a new GMP manufacturing facility. The ideal candidate will provide technical oversight for lyophilization and isolator systems while working closely with Engineering, CQV, and Operations teams to ensure successful equipment installation, startup, commissioning, and GMP readiness.

Key Responsibilities

• Provide technical support for the installation, startup, and commissioning of lyophilizers, isolators, and associated aseptic process equipment.
• Collaborate with CQV teams to support commissioning, qualification, and equipment turnover activities.
• Coordinate with vendors, contractors, and cross-functional teams throughout project execution.
• Support Process Hazard Analyses (PHAs) and ensure equipment is implemented in accordance with GMP and site safety requirements.
• Troubleshoot equipment issues during startup and support operational readiness.
• Ensure compliance with GMP requirements throughout equipment startup and commissioning.
• Assist with engineering documentation and process improvement activities.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 5 years of engineering experience in pharmaceutical or biotech manufacturing.
• Hands-on experience with lyophilization (freeze dryers), isolator systems, or aseptic processing equipment.
• Experience supporting GMP equipment startup, commissioning, and qualification activities.
• Familiarity with CQV (Commissioning, Qualification & Validation) processes.
• Experience supporting facility startups, equipment installation, and commissioning projects.
• Knowledge of sterile pharmaceutical manufacturing and GMP regulations.
• Experience participating in Process Hazard Analyses (PHAs) is preferred.
• Strong communication, troubleshooting, and cross-functional collaboration skills.