What are the responsibilities and job description for the Process Engineer - Lyophilization & Isolator Systems position at Stark Pharma Solutions Inc?
Hi,
My name is Sravani Dasari, from Vakula Tech Inc. We are hiring talented professionals for a Process Engineer - Lyophilization & Isolator Systems position. If you have relevant experience and are interested in this opportunity, please send me your updated resume. The detailed job description is as follows.
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.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Vakula Tech on LinkedIn for the latest job updates:
https://www.linkedin.com/company/vakula-tech
Thank you,
Sravani Dasari
Talent Acquisition Specialist
Vakula Tech Inc.
Email: jobs@vakulatech.com
Piscataway, New Jersey 08854
Website: www.vakulatech.com