Pharmaceutical Process Development Expert
5 days ago
Company Overview: Bryllan LLC is a rapidly growing Contract Manufacturing Organization (CMO) dedicated to delivering high-quality sterile filling and containment solutions for pharmaceutical products. Our unique platform enables multi-product filling of cytotoxic, potent, live virus, and vaccine drug products.
Salary: Compensation for this role will be determined based on the candidate's experience level. A senior-level Process Engineer title with a higher salary may be considered for applicants with extensive pharmaceutical industry experience.
Job Description: As a Process Engineer at Bryllan LLC, you will oversee technical transfer activities for sterile injectable pharmaceutical products. This involves driving quality into production processes, implementing best practices, and ensuring continuous improvement. Your expertise will be critical in providing focused process knowledge and technical support to ensure high-quality and efficient products.
Key Responsibilities:
- Support development, transfer, and validation of manufacturing processes, including cleaning validation.
- Ensure quality standards and best practices are maintained throughout the transfer process.
- Develop, author, and maintain documents supporting various steps in transferring products.
- Provide routine process technical support and troubleshooting for resolving manufacturing issues.
- Offer technical training on processes and/or equipment as required.
- Act as assigned technical lead and owner of manufacturing process systems.
- Develop and maintain productive links with process technology suppliers and vendors.
- Lead/represent Technical Operations on project teams, overseeing SME technical oversight and management of technical issues or changes.
- Participate in project teams for new equipment needed in support of manufacturing activities.
- Anticipate potential process-related problems, risks, and technical conflicts, developing contingency plans for business continuity.
- Conduct work activities strictly in accordance with safety guidelines and processing standard cGMP's and SOP's.
Required Skills and Qualifications:
- 2+ years of experience in the pharmaceutical industry; 10+ years preferred.
- Comprehensive knowledge of cGMP and regulatory principles.
- 4-year degree in Engineering, Science, or equivalent, with preference for process, chemical, or mechanical disciplines.
- Demonstrated ability to write, edit, understand, and follow SOP's.
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