Process Engineer (API Manufacturing)

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: Process Engineer (API Manufacturing)
Location: Sacramento, CA
Duration: Long Term

Job Overview

We are seeking an experienced Process Engineer with 5+ years of experience in API manufacturing and chemical processing environments. The ideal candidate will have hands-on experience supporting GMP manufacturing operations, process troubleshooting, equipment startup, process optimization, and manufacturing documentation. This individual will provide technical engineering support to improve manufacturing safety, quality, and productivity while ensuring compliance with established GMP and process safety standards.

Key Responsibilities

Provide technical engineering support for API manufacturing processes, including process scale-up, equipment startup, troubleshooting, and production optimization.
Develop, review, and revise manufacturing documentation, including batch records, work instructions, cleaning procedures, and GMP-related documents.
Lead process improvement initiatives to reduce downtime, improve cycle times, and enhance manufacturing safety, quality, and productivity.
Support equipment setup, facility and equipment qualification, product changeovers, and manufacturing process improvements.
Troubleshoot manufacturing equipment and process-related issues involving reactors, centrifuges, dryers, mills, and other production equipment.
Lead technical investigations and collaborate with Manufacturing, Quality, and Engineering teams to resolve production challenges.
Support operator training and ensure manufacturing activities comply with established safety and quality standards.

Required Qualifications

5+ years of experience in Process Engineering or API manufacturing.
Strong chemical engineering background with hands-on experience in regulated manufacturing environments.
Experience with GMP process troubleshooting, process optimization, and equipment startup.
Hands-on knowledge of API manufacturing equipment, including reactors, centrifuges, dryers, mills, and related equipment.
Experience developing and maintaining manufacturing documentation, batch records, work instructions, and cleaning procedures.
Knowledge of process safety and manufacturing operations.
Experience supporting equipment setup, qualification, and production activities.
Strong technical troubleshooting, problem-solving, and communication skills.
Ability to independently manage engineering activities with minimal supervision.
Experience with PHA/PSSR, CAPA investigations, equipment qualification, P&IDs, mass balance calculations, and emission calculations is a plus.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

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