Process Development Engineer
4 days ago
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization. Our team works closely with clients to provide trusted partnership and recognized industry expertise.
Job SummaryThe Senior Process Engineer is responsible for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing at our RTP facility. Key responsibilities include:
- 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.
On-Site Expectations
- 100% on-site position
- 1st Shift: Monday - Friday, 8:00am - 5:00pm
The Senior Process Engineer will:
- Provide technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
- Write Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
- Monitor manufacturing processes during production runs to assess any technical process issues and provide troubleshooting support as needed
- Autorize manufacturing investigations and complete CAPA assignments
- Compose process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
- Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products
- Interact with clients during routinely scheduled project meetings
- Ensure timely completion and compliance with cGMP and all other relevant company training requirements
Qualifications
- 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
The ideal candidate will have:
- Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required
- Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes
- Working knowledge of EU regulations preferred
- Proficiency with Microsoft office (Word, Excel, Outlook) required
- Ability to interact with internal stakeholders and external customers
Travel Expectations
- Up to 5% domestic travel
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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