Senior Process Engineer

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:

Senior Process Engineer

Location:

Indiana

Duration:

Long Term

Job Overview

We are looking for a Senior Process Engineer to support pharmaceutical manufacturing operations and drive process improvements across the site. The role focuses on optimizing fill line and isolator performance, aseptic process troubleshooting, automated vial filling equipment, and process improvement within a cGMP environment. The ideal candidate will have hands-on experience with Optima filling equipment, particularly the Optima H610, along with experience supporting filling operations, isolators, autoclave processes, and formulation activities.

Key Responsibilities

• Drive process improvements across pharmaceutical manufacturing operations.
• Optimize fill line and isolator performance.
• Support troubleshooting of aseptic processing and manufacturing issues.
• Provide hands-on support for Optima filling equipment, including Optima H610.
• Support automated vial filling equipment and associated support systems.
• Troubleshoot filling line performance and process-related issues.
• Support formulation, filling, and autoclave operations.
• Develop, revise, and maintain SOPs, batch records, and other process documentation.
• Identify opportunities to improve process efficiency, reliability, and manufacturing performance.
• Support process improvement initiatives within a cGMP manufacturing environment.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams.
• Support manufacturing operations in a fast-paced and growing environment.

Required Qualifications

• Bachelor s degree in Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Experience in pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience with Optima filling equipment.
• Experience With Optima H610 Is Required.
• Experience with aseptic process troubleshooting.
• Experience with vial filling operations and automated filling equipment.
• Experience working with isolators and associated support systems.
• Familiarity with autoclave and formulation processes.
• Strong process engineering and troubleshooting skills.
• Experience working in a cGMP environment.
• Strong technical documentation and communication skills.
• Reliability engineering experience is a plus.
• Ability to work effectively in a fast-paced manufacturing environment.

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