3key Consulting, Inc.
Engineer, Facilities, Equipment and Analytical support (JP12166)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Job Title:
Engineer, Facilities, Equipment and Analytical Support (JP12166) Location:
Thousand Oaks, CA. 91320 Business Unit:
F&E Drug Substance Supply Employment Type:
Contract Duration:
1+ year(s) (with possible extensions) Rate:
$38 - $42/hour W2 Posting Date:
01/12/2024 Notes:
Only qualified candidates need apply. Fully onsite. 3 Key Consulting is recruiting an
Engineer, Facilities, Equipment and Analytical Support
for a consulting engagement with our client, a leading global biotechnology company. Job Description:
This position supports manufacturing activities related to cGMP equipment and facilities at the Thousand Oaks site. The engineer will lead activities aligned with the client’s Commissioning and Qualification Process (CQP) to ensure GMP equipment is installed and maintained in a validated state. The role involves collaboration with maintenance, project management, engineering, and manufacturing teams to develop, oversee, and ensure the reliability and GMP compliance of equipment. The engineer will also evaluate maintenance plans, support periodic reviews, investigate equipment issues, and work with process development and validation teams to develop practices for characterization. Top Must Have Skill Sets: Fundamental client leadership and values; experience with former client organizations preferred Excellent communication, safety, and quality focus Fundamental technical knowledge Strong analytical skills and background, with experience working in a manufacturing environment Day to Day Responsibilities: Lead verification activities in line with CQP for GMP equipment installation and validation Collaborate with maintenance, project management, engineering, and QA teams Evaluate equipment maintenance plans and support review of manufacturing systems Conduct root cause analysis for equipment issues using LEAN tools Develop validation protocols, oversee their execution, and ensure GMP and safety compliance Review and approve validation reports and documentation Participate in multidisciplinary teams and support process improvements Provide technical support during project execution and troubleshooting Basic Qualifications: Master’s degree OR Bachelor’s degree with 2+ years of experience OR Associate degree with 6+ years of experience OR High school diploma/GED with 8+ years of experience Preferred Qualifications: Bachelor’s in engineering or related science field 2+ years relevant manufacturing or operations experience Experience with regulated environments (FDA, OSHA, EPA) Knowledge of cGMP procedures, validation, and engineering practices in pharma/biotech Experience with risk-based verification and validation protocol development Strong communication and technical writing skills Team player with experience in process improvement methodologies (LEAN, Six Sigma) Problem-solving skills and ability to support outside regular hours Red Flags: Safety not prioritized Poor communication Stress management issues Blame-shifting behaviors Interview Process:
One phone interview and one virtual panel interview. Qualified candidates are invited to send their resume to
resumes@3keyconsulting.com . For other opportunities, visit
our careers page . Feel free to share this opportunity with interested colleagues.
#J-18808-Ljbffr
Engineer, Facilities, Equipment and Analytical Support (JP12166) Location:
Thousand Oaks, CA. 91320 Business Unit:
F&E Drug Substance Supply Employment Type:
Contract Duration:
1+ year(s) (with possible extensions) Rate:
$38 - $42/hour W2 Posting Date:
01/12/2024 Notes:
Only qualified candidates need apply. Fully onsite. 3 Key Consulting is recruiting an
Engineer, Facilities, Equipment and Analytical Support
for a consulting engagement with our client, a leading global biotechnology company. Job Description:
This position supports manufacturing activities related to cGMP equipment and facilities at the Thousand Oaks site. The engineer will lead activities aligned with the client’s Commissioning and Qualification Process (CQP) to ensure GMP equipment is installed and maintained in a validated state. The role involves collaboration with maintenance, project management, engineering, and manufacturing teams to develop, oversee, and ensure the reliability and GMP compliance of equipment. The engineer will also evaluate maintenance plans, support periodic reviews, investigate equipment issues, and work with process development and validation teams to develop practices for characterization. Top Must Have Skill Sets: Fundamental client leadership and values; experience with former client organizations preferred Excellent communication, safety, and quality focus Fundamental technical knowledge Strong analytical skills and background, with experience working in a manufacturing environment Day to Day Responsibilities: Lead verification activities in line with CQP for GMP equipment installation and validation Collaborate with maintenance, project management, engineering, and QA teams Evaluate equipment maintenance plans and support review of manufacturing systems Conduct root cause analysis for equipment issues using LEAN tools Develop validation protocols, oversee their execution, and ensure GMP and safety compliance Review and approve validation reports and documentation Participate in multidisciplinary teams and support process improvements Provide technical support during project execution and troubleshooting Basic Qualifications: Master’s degree OR Bachelor’s degree with 2+ years of experience OR Associate degree with 6+ years of experience OR High school diploma/GED with 8+ years of experience Preferred Qualifications: Bachelor’s in engineering or related science field 2+ years relevant manufacturing or operations experience Experience with regulated environments (FDA, OSHA, EPA) Knowledge of cGMP procedures, validation, and engineering practices in pharma/biotech Experience with risk-based verification and validation protocol development Strong communication and technical writing skills Team player with experience in process improvement methodologies (LEAN, Six Sigma) Problem-solving skills and ability to support outside regular hours Red Flags: Safety not prioritized Poor communication Stress management issues Blame-shifting behaviors Interview Process:
One phone interview and one virtual panel interview. Qualified candidates are invited to send their resume to
resumes@3keyconsulting.com . For other opportunities, visit
our careers page . Feel free to share this opportunity with interested colleagues.
#J-18808-Ljbffr