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Validation Engineer - (JP9979)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Validation Engineer - (JP9979)
Location: Thousand Oaks, CA. 91320
Employment Type:  Contract
Business Unit: MEM Test Automation
Duration: 1+ years (with likely extensions)
Notes:  Hybrid role; until COVID restrictions lift (must do all lab work onsite).
Posting Date:  03/22/2022

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

Job Description:
This position involves the support of senior staff in the initiation, design, and delivery of projects, particularly for automation-related scope in the Process Development Organization, within the Commercial Platform Methods and Automation (CPO). This candidate will be a member of the Commercial Platform Methods and Automation team; will work on GMP Physical Test Methods, integrated testing machines, and their lifecycle management. 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 utilize automatic data transfer between various systems. They will have to understand use cases and business needs throughout the organization and build data processes and visualizations to help teams employ this data. Assist with project definition by performing engineering studies and assessments 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 get opportunities to apply their expertise to make decisions on enhanced data management.

Why is the Position Open?

Top Must-Have Skill Sets:
  • Basic knowledge of engineering principles and statistical concepts in data assessment, like GR&R
  • Knowledge on coding and configuring of PLC control systems like Rockwell\Allen Bradley, Siemens, LabVIEW, or laboratory measurement systems
  • Knowledge of databases like SQL/spark SQL and the ability to manipulate large datasets from various source systems/databases
  • BS in Engineering
  • 1-2 years of experience or proven intern experience

Day to Day Responsibilities:
  • Generate Equipment and Automation Lifecycle Documents like URS, Functional Specifications, Design Specifications, Data Integrity Assessments, Validation Plans, and Protocols
  • Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
  • Work on troubleshooting various lab instrumentation and automation with the required knowledge of the software controlling the instruments and integrated systems.
  • 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 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

Employee Value Proposition:
  • Client is a special pharma company
  • Working on drug device and methods
  • Gain valuable experience in industry
  • Growth in career

Red Flags:
  • Lack of interest in engineering work.
  • Lack of handy experience.
  • Lack of excellent verbal and written communication skills.

Interview process:
  • Phone interview first
  • WebEx group interview

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