3 Key Consulting, Inc.

Validation Engineer (JP9807)

3 Key Consulting, Inc.  •  Cambridge, MA (Onsite)  •  1 month ago
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Job Description

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.

  • 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.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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