- Support lifecycle engineering of Upstream Bioprocessing hardware products, components, and assemblies through design, testing
- Analyze and validate designs per user requirements to meet performance, cost, compliance, and manufacturability targets.
- Author design verification and validation documentation, and develop test methods, test procedures and work instructions.
- Modify electrical schematics.
- Support customer complaint investigations by troubleshooting, conducting product testing, Root Cause Analysis.
- Perform product risk assessment and product quality investigations.
- Closely monitor and track project schedules against agreed milestones, including supporting identification and management of relevant critical paths and dependencies.
- Proactively identify project issues and risks, support issue resolution, and develop risk mitigation plans in close partnership with project teams and relevant business partners.
- Proactively build relationships across various functions and levels across the organization to ensure effective stakeholder management.
- Lead project team meetings, including agenda development, meeting facilitation, and documentation of meeting minutes.
- Create and present project updates to communicate status, issues and risks.
- Requires a bachelors or masters degree in mechanical engineering, Electrical Engineering, or related discipline. Looking for 3 plus years of experience in the biotech-pharmaceutical academic or industrial environment.
- Experience with Commissioning and Qualification.
- Electrical CAD drafting skills
- Strong technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc. in addition to experience working within shared work environments.
- Travel within USA as needed for the projects.
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Project Engineer - Boston, United States - Trinity Consultants
Description
ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team
Requirements:
Qualifications: