3key Consulting, Inc.
Overview
Job Title:
Engineer, Biotech Location:
Thousand Oaks, CA Employment Type:
Contract Duration:
12 months with possible extensions or conversion to FTE Rate:
$40 - $44/hour Posting Date:
05/22/2024 Summary
The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long-term strategy. Responsibilities
Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment. Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications. Suggest design modifications to address risks and design in quality and safety. Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach). Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards. Recommend, evaluate, and manage performance of contract resources Provide oversight for verification deliverables developed by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation Basic Qualifications
Doctorate degree OR Master’s degree & 3 years of engineering and/or manufacturing experience OR Bachelor’s degree & 5 years of engineering and/or manufacturing experience Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or another science-related field 7+ years of relevant work experience with 5+ years’ experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Interview Process
One phone and one virtual panel interview. How to Apply
We invite qualified candidates to send your resume to
recruiting@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.
#J-18808-Ljbffr
Job Title:
Engineer, Biotech Location:
Thousand Oaks, CA Employment Type:
Contract Duration:
12 months with possible extensions or conversion to FTE Rate:
$40 - $44/hour Posting Date:
05/22/2024 Summary
The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long-term strategy. Responsibilities
Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment. Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications. Suggest design modifications to address risks and design in quality and safety. Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach). Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards. Recommend, evaluate, and manage performance of contract resources Provide oversight for verification deliverables developed by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation Basic Qualifications
Doctorate degree OR Master’s degree & 3 years of engineering and/or manufacturing experience OR Bachelor’s degree & 5 years of engineering and/or manufacturing experience Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or another science-related field 7+ years of relevant work experience with 5+ years’ experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Interview Process
One phone and one virtual panel interview. How to Apply
We invite qualified candidates to send your resume to
recruiting@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.
#J-18808-Ljbffr