Actalent Process Engineer in Lexington, Massachusetts
This assignment will support the development of drug-device combination products and support the downstream manufacture of clinical trial materials of a drug-device combination product and ancillary device. Candidates for this assignment will be able to interact with external and internal stakeholders and suppliers, understand complex processes, and help analysis process data, coordinate supplier and testing activities and manage and coordinate preparation of R&D development material and/or clinical trial material support of the product development pipeline.
Monitor the manufacture of clinical and research materials in the combination platform 25%
Interact with multiple external vendors such as sterilization, analytical, and logistics providers 25%
Report status of clinical material manufacture to relevant internal stakeholders 25%
Hands on method development and troubleshooting in the Lexington research lab 25%
• Attend weekly meetings with external CMOs and CROs to align on key deliverables
• Track the movement of materials across the supply chain, including US and EU.
• Conduct studies and/or data analyses and Prepare reports on research initiatives and continuous process improvement initiatives.
• Clinical supply chain manufacture requires adherence to policies and procedures as defined. Individual will be expected to respond to quality events and non-conformances with communication and collaboration, both internally and externally.
Required Skills & Qualifications:
• B.S. or M.S. in a relevant technical discipline (chemical, mechanical, biomedical, materials, pharmaceutical engineering or related field)
• Related Engineering Experience: 2 to 6 years
• Familiarity with GMP
• Previous experience in a regulated environment
• Able to efficiently multi-task under time constraints
• Able to work with minimal supervision
• Excellent written and oral communication skills
Preferred Skills & Qualifications:
• Previous pharmaceutical and/or device industry experience is a plus
• Previous experience with 3D printing is a plus
• Previous experience with extrusion processes is a plus
• Previous experience with CAD (SolidWorks preferred) is a plus
• Previous experience in a GMP and Design Control (CFR-820) and ISO13485 regulated environment.
• Demonstrates good laboratory wet chemistry experience
• Attention to detail in documentation
• Experience with Microsoft Excel, Word, and PowerPoint
• Gage R&R Studies, Process Capability Studies and Designs of Experiments.
• Familiarity with Statistical Process Control
• Experience with Minitab
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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