Job Description
Insight Global is seeking a Process Engineer (Sterile) II to support a pharmaceutical manufacturing client of ours in Charleston, SC. This individual will provide hands‑on technical support in a fast‑paced manufacturing environment, supporting process validation, technology transfer, investigations, and continuous improvement initiatives.
Key Responsibilities
- Provide technical support for sterile manufacturing processes, including process transfer and validation activities
- Analyze existing manufacturing processes and implement improvements to increase efficiency, reduce costs, and improve product quality
- Develop or modify processes, equipment, and layouts to meet production goals
- Author and execute process validation, cleaning validation, and process optimization protocols
- Define critical process parameters, sampling plans, and testing requirements
- Write validation reports and technical improvement documentation
- Monitor manufacturing processes during production runs and troubleshoot issues
- Support aseptic operations, including sterilization, depyrogenation, lyophilization, and sanitization
- Participate in deviations, investigations, and CAPAs
- Utilize FMEA to troubleshoot and mitigate processing risks
- Support capital projects, including scope development and design review
- Ensure compliance with cGMPs and all required training
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• Bachelor’s degree in Engineering
• 3+ years of experience supporting sterile pharmaceutical manufacturing
• Experience with process validation, investigations, and technology transfer
• Strong working knowledge of cGMP
Nice to Have Skills & Experience
• Parenteral (injectable) manufacturing
• Liquid fill dosage forms
• Lyophilization and sterilization processes
• Process scales up and optimization
• Pharmaceutical technology transfer
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.