Process & Technology Transfer Engineer I
$73,000–$85,000 year
On-site · Rockville, Maryland, United States
Job Summary
The Process and Technology Transfer Engineer I will oversee and lead the technology transfer process for Contract Manufacturing Organizations. Responsibilities include providing technical support for manufacturing scale-up, preparing and reviewing study protocols and technical reports, and ensuring compliance with regulatory and quality standards. The role requires a bachelor's degree in engineering, two years of relevant industry experience, and a working knowledge of cGMP requirements. Statistical analysis skills and proficiency in Microsoft Office are also essential.
Required Qualifications
- Bachelors degree in engineering or related fields
- A minimum of two years of relevant industry experience in manufacturing, process development, scale-up, technology transfer and process validation
- Working knowledge of cGMP requirements related to Drug Product manufacturing processes
- Demonstrated ability to solve complex technical problems with the use of data
- Ability to work independently and as part of a team
- Capable of performing other duties as assigned by Management
- Authorized to legally work in the United States without visa sponsorship
Desired Qualifications
- Previous experience writing equipment validation protocols or technical writing
- Previous experience working with Statistical models and conducting statistical analyses
- Strong communication skills (written and verbal)
- Proficiency with Microsoft office (Word, Excel, Outlook)
Additional Requirements
- Authorized to legally work in the United States without visa sponsorship
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