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HIPPA Troubleshoot GCP SOP FDA Problem Solving Skills Engineer
(Jobs in Waltham,
 
Requirement id 112840
Job title Engineer
Job location in Waltham, MA
Skills required HIPPA, Written And Oral Communications Skills, Troubleshoot, GCP SOP FDA Problem Solving Skills
Open Date 08-Jan-2021
Close Date
Job type Contract
Duration 6 Months
Compensation DOE
Status requirement ---
Job interview type Face to Face interview
   Email Recruiter: coolsoft
Job Description Engineer: HIPPA, Written And Oral Communications Skills, Troubleshoot, GCP SOP FDA Problem Solving Skills

Candidate must be our W2 Employee.

Job Description:

Opening in Waltham, MA!

Client combines with parent company On Assignment to make it the 2nd largest IT staffing agency in the country.

Client has an opportunity for a Lab Automation Engineer role in Waltham, MA. Here are the details:

Position: Lab Automation Engineer

Location: Waltham, MA

Rate: Negotiable

Duration: PERMANENT

The Automation Engineer will help define, design, expand, optimize, and maintain our automated laboratory workflows for current and pipeline diagnostic applications. This position requires a proactive individual who will quickly grasp big picture requirements and is equally capable of execution within a fast-paced environment of shifting priorities. The Automation Engineer also contributes in the transfer of newly developed assays from the development stage to routine practice in the laboratory (internally and externally) in a manner that is consistent with the company goals and in compliance with the Quality Management System.

Day to Day Responsibilities:

Program and maintain liquid handling robotic platforms for automation of Dx and CDx workflows, including but not limited to proprietary exosome extraction, qPCR, NGS.

Integrate automated methods to ensure proper sample tracking.
Prepare SOPs for automated workflows.

Coordinate with our Quality team to validate automated workflows.

Install, validate, and maintain laboratory instrumentation platforms, tools, and automation suites to drive high throughput processes.

Perform troubleshooting and other sustaining activities (e.g. – calibration) to keep automated solutions operating optimally.

Work collaboratively with our CLIA operations and R&D teams to develop, optimize, and validate application-specific protocols on Hamilton, Tecan, and/or Perkin Elmer and other complex automated instrumentation, including integration of third-party devices.

Liaise with Customer Service, QA, QC, Dx Sales, CDs/Business Development, CLIA Operations, R&D and

Marketing teams to ensure that proposed solutions meet customer needs.

Execute validations in compliance with appropriate regulatory requirements.

Provide training on use, maintenance and troubleshooting of automation equipment to staff with varying scientific and automation skills.

Design solutions to improve performance (cycle time, reliability, etc.) and to ensure quality and stability of automation systems through future expansions, upgrades and/or replacements.

Maintain proper documentation to ensure all maintenance and validations are compliant.

Support various departments in coordinating and timely execution of development milestones, product launches, new product and process development, line extensions, and support of existing products.

Follow company policies and practices as outlined in all company resources, including, but not limited to, safety and compliance guidelines.

Required Skills:

Bachelors degree in any biological science or engineering discipline with 4+ years of experience in a laboratory setting or MS with 2+ years of relative work experience, in engineering, bioengineering, computer science or applied science field.

Must have Expert knowledge of at least one commercial liquid handling robotics platform (Hamilton, Tecan, and/or Perkin Elmer preferred) and extensive experience programming for other platforms

Experience porting complex workflows onto automated/robotics platforms is required.

Experience supporting laboratory operations in a GCP/GCLP environment is highly preferred.

Experience working with FDA regu
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 112840 while calling.
 
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(Engineer: HIPPA, Written And Oral Communications Skills, Troubleshoot, GCP SOP FDA Problem Solving Skills in Waltham, MA)
     
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