Senior Pharmaceutical Manufacturing Specialist
5 days ago
We are seeking a highly skilled Senior Process Engineer to join our team at Alcami. As a key member of our manufacturing team, you will play a vital role in driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing at our RTP facility.
About the RoleThe Senior Process Engineer will be responsible for:
- Providing technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
- Writing Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
- Monitoring manufacturing processes during production runs to assess any technical process issues and providing troubleshooting support as needed
You will work closely with our team to ensure timely completion and compliance with cGMP and all other relevant company training requirements.
Key Responsibilities
- Performing tech transfers of new processes and technologies into the site
- Preparing documentation to support process validation and batch manufacturing
- Troubleshooting manufacturing processes
- Completing process deviations and investigations
- Coordinating lab studies with the formulation development lab
These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.
Requirements
- Bachelor's degree in Engineering, Pharmacy, or Chemistry
- 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment
- Previous experience supporting tech transfer of parenteral Drug Products preferred
What We Offer
- A competitive salary and benefits package
- Ongoing training and professional development opportunities
- A collaborative and dynamic work environment
We are committed to creating a diverse and inclusive workplace that reflects the communities we serve. If you are passionate about delivering high-quality results and making a real difference, we encourage you to apply.
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