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Pharmaceutical Process Engineer
Location:
Brighton, MI
Description:
Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan differentiates itself from our competitors by living our values of Integrity, Quality and Service. The Process Engineer will oversee the technical transfer activities of sterile injectable pharmaceutical products at Bryllan LLC for our customer projects. This role requires strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. The incumbent will provide focused process knowledge and the technical expertise to ensure high quality and efficient sterile injectable products.As a member of the technical operations team, the Process Engineer is responsible to: Support the 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 that support hte various steps necessary in transferring products. This many include: engineering studies, risk assessments, batch records, process flow diagrams, validation protocols and reports, SOP's, investigations and other technical documentation. Provide routine process technical support and troubleshooting for resolution of manufacturing issues. Provide technical training on process 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 where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle while insuring overall project objectives of scope and schedule are adhered to. Participate in project teams for various new equipment needed in support of manufacturing activities. Anticipate potential process related problems,risks and technical conflicts and develop the necessary contingency plans that optimize business continuity. Ensure work activities are conducted in strict accordance with safety guidelines and processing standard cGMP's and SOP's. Candidates must possess a strong work ethic and ability to accomplish tasks without supervision, exhibit leadership, thrive in a fast paced environment, excellent communication skills, superior math and organizational skills, commitment to the highest ethical and legal standards, treat others with respect.The following qualifications are the minimum required for this role: 5+ years of experience in the pharmaceutical industry. 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.
Company:
Bryllan
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Pharmaceutical Process Engineer
Pharmaceutical Process Engineer is a Engineering Process Engineer Job at Bryllan located in Brighton MI. Find other listings like Pharmaceutical Process Engineer by searching Oodle for Engineering Process Engineer Jobs.
Pharmaceutical Process Engineer is a Engineering Process Engineer Job at Bryllan located in Brighton MI. Find other listings like Pharmaceutical Process Engineer by searching Oodle for Engineering Process Engineer Jobs.