Project Engineer 2-3

Concuir, Inc•Vacaville, CA

2h•$100,000 - $150,000•Hybrid

About The Position

As a full-time employee of Concuir, Inc, you will provide consulting services to pharmaceutical, biotech, and/or medical device manufacturing clients. In this role, you will quickly learn common client practices, be in a position to recommend and implement improvements to reach project goals, and have the opportunity to work with amazing clients who are bringing life-changing and/or saving life science products to patients. You will be able to utilize your education and experience and benefit from Concuir’s mentorship and project management portfolio and cGxP best practices to drive your overall success. Projects range from design through qualification of production equipment, utilities modification, implementation of new facilities, and process scale-ups. You will drive to understand our unique client needs to deliver successful results. Providing excellent customer service to our clients and ultimately the patients they serve is critical. Your Concuir leadership will work with you to guarantee internal processes and support are in place to ensure your positive results. You will execute projects day-to-day for your clients with mentorship and technical problem-solving collaboration from your manager and team. You will interface with process owners and project stakeholders to reach our clients' objectives. This includes resolving critical issues and gathering appropriate feedback from the team. Depending on the scope and project complexity, you may be responsible for delivering between 1 and 3 projects concurrently.

Requirements

2-10+ years of experience working on capital or expense projects in the Pharmaceutical, Biotech, or Medical Device industry.
BS Engineering degree required, Chemical, Mechanical, or Biomedical preferred.
Self-starter with strong communication skills, both verbal and written.
Ability to work with and build good relationships with stakeholders and the wider site teams.

Nice To Haves

Demonstrated expertise in product development, process development, process validation, technology transfer, scale-up, CSV, GMP, and technical writing is a plus.

Responsibilities

Perform Capital and/or Expense project deliverables on time, within cost, and meet goals.
Drive client and stakeholder satisfaction through fulfilling project expectations.
Facilitate team communication and accountability by appropriately escalating issues.
Participate in cross-functional teams dedicated to process improvement, efficiency, and optimization.
Provide troubleshooting and start-up of process equipment and utilities.
Generate and revise documents such as engineering specifications, risk assessments, gap assessments, etc., to support process equipment, critical utilities, and manufacturing processes.
Knowledge of equipment use, process techniques/troubleshooting, and participation in technology transfer, equipment installation/construction, and scale-up for clients.
Provide technical assessments for investigations, validation, CAPAs, and change control.
Execute studies and comparability protocols for manufacturing operations.
Create an experimental design under a supervisor’s direction and perform independent execution.