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Validation Engineer (JP9807)

Cambridge, Massachusetts · Biotech/Pharmaceutical
Job Title:  Validation Engineer (JP9807)
Location: Cambridge, Massachusetts 02138
Employment Type: Contract
Business Unit: Commercial Platform Methods and Automation
Duration: 12 months with likely extensions
Job posting date: 2/16/2022
Note: Partially onsite 3-4 days weekly

3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope in the Process Development Organization, within the Final Product Technologies (FPT).
  • This candidate will be a part of the Commercial Platform Methods and Automation team which, in addition to lifecycle management of Physical GMP Test Methods, manages lifecycle of integrated testing machines.
  • Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation.
  • The candidate will work cross-functionally to help the team make use of automatic data transfer between various systems.
  • They will have to understand use cases and business need throughout the organization and build data processes and visualizations to help teams best-utilize this data.
  • Assist with project definition by performing engineering studies and assessment for automation system installations.
  • Perform field evaluations of existing systems and provide engineering design recommendations.
  • The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables.
  • This individual has a passion for modeling, analytics, and technology.
  • The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions.
  • collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
  • Troubleshooting of various lab instrumentation and automation, which will require skill of the software controlling the instruments and integrated systems.
  • Optimizing workflows and protocols to increase throughput, improve data quality, and/or reduce consumable consumption.
  • Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
  • Developing, enhancing, automating, and managing test data
  • Network with manufacturing and quality organizations internal to the client.
  • Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented in SOPs
  • Monitoring technological developments in the field & evaluation of new technologies

    Basic Qualifications:
    Mechanical or electrical engineering degree or bioengineering.

Top Must have Skill Sets:
  • Knowledge of engineering principles and concepts like GR&R, equipment characterization
  • Knowledge on validation of control systems and/or laboratory measurement systems
  • Knowledge on databases like SQL/spark SQL and ability to manipulate large datasets from various source systems/databases.

Day-To-Day Responsibilities:
  • Develop and execute Equipment validation
  • Keep projects schedules
  • Provide status to internal clients

Employee Value Proposition:
The person in this role will work with a CTM machine and other new machines. You will do end to end task on machines that will be used in manufacturing. You will also gain experience using validation software.

Red Flags:
This is a very hands-on positions. A person who is only interested in filling out documentation will not be a good fit.

Interview Process:
Phone Screening
Panel Interviews 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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