Sr. Process Engineer

Stark Pharma Solutions Inc; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. in Indiana is seeking a Sr.

Process Engineer with radiopharmaceutical manufacturing experience to support startup, commissioning, troubleshooting, maintenance and new equipment introduction while collaborating with Engineering, Maintenance, Manufacturing and Quality teams. The role requires a Bachelor's degree in Engineering, experience with isolators or containment equipment, and strong problem-solving and GMP documentation knowledge.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Experience in radiopharmaceutical manufacturing.
• Experience with isolators or containment equipment.
• Experience with equipment commissioning, startup, and maintenance.

Responsibilities

• Support startup, commissioning and troubleshooting of pharmaceutical manufacturing equipment.
• Assist with equipment installation, startup, and qualification activities.
• Coordinate with Engineering, Maintenance, Manufacturing, and Quality teams.
• Maintain GMP engineering documentation and change controls.
• Support deviations, CAPAs and root cause investigations.
• Assist with new equipment introduction and improvements.
• Support equipment qualification and validation activities.
• Ensure compliance with GMP and regulatory requirements.

Skills

Strong problem-solving

Excellent communication

Education

Bachelor's degree in Engineering or related technical field

Tools

Radiopharmaceutical equipment

Isolators/Containment equipment

Equipment troubleshooting

Process validation

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Position: Sr. Process Engineer

Location: Indiana

Duration: Long Term

Job Overview

We are seeking a Sr. Process Engineer with radiopharmaceutical manufacturing experience to support new and existing pharmaceutical manufacturing equipment. The role will focus on equipment startup, commissioning, troubleshooting, maintenance, and new equipment introduction while working closely with Engineering, Maintenance, Manufacturing, and Quality teams.

Key Responsibilities

• Support new and existing pharmaceutical manufacturing equipment.


• Support equipment installation and startup activities.


• Assist with commissioning and equipment troubleshooting.


• Support new isolator and containment equipment.


• Partner with Engineering and Maintenance teams.


• Support preventive and corrective maintenance activities.


• Troubleshoot equipment and process issues.


• Support root cause investigations.


• Support deviations, CAPAs, and change controls.


• Maintain GMP engineering documentation.


• Support equipment qualification and validation.


• Support equipment modifications and improvements.


• Assist with new equipment introduction activities.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.


• Experience in radiopharmaceutical manufacturing is required.


• Experience with pharmaceutical manufacturing equipment.


• Experience with isolators or containment equipment.


• Experience with equipment troubleshooting and maintenance.


• Experience with equipment commissioning and startup.


• Experience with new equipment introduction.


• Knowledge of GMP documentation and engineering processes.


• Experience supporting equipment qualification and validation.


• Strong problem-solving and communication skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.