3key Consulting, Inc.
Engineer Senior - Technical Support GMP Manufacturing (JP12779)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Job Title:
Engineer Senior Technical Support GMP Manufacturing (JP12779) Location:
Thousand Oaks, CA. 91320 Business Unit:
Facilities and Equipment Drug Substance Supply Employment Type:
Contract Duration:
1+ years (with possible extensions) Rate:
$45 - $50/Hr, with benefits Posting Date:
6/24/2024 Notes:
Only qualified candidates need apply. Fully onsite. Standard business hours 3 Key Consulting is hiring! We are recruiting an
Engineer Senior
for a consulting engagement with our client, a leading global biotechnology company. Job Description: Looking for hands-on
strong
engineer experience with proper training/background in technical skills/mathematics. This role is NOT for quality lab, bench top, or science work. Candidates should be practical in troubleshooting and able to hold technical conversations. Transferable industry backgrounds include drug substance, pharma, chemical, oil refinery, or mechanical sectors. This position supports manufacturing activities related to cGMP equipment and facilities at our client’s Thousand Oaks, CA. site. The senior engineer collaborates with automation, maintenance, project management, corporate engineering, and manufacturing teams to develop and oversee equipment operation and reliability, ensuring safety and quality compliance. Responsibilities include supporting department and capital projects, providing data for business cases and strategy, and offering direct technical support. The engineer's key responsibilities include: Modeling leadership behaviors to foster a positive work environment. Ensuring manufacturing equipment reliability and managing key capital projects. Identifying critical quality parameters and process attributes for equipment or facility modifications. Suggesting design modifications for risk mitigation and quality/safety enhancement. Developing commissioning strategies based on URS and QRAES to validate equipment design, minimizing costs and schedule impact. Overseeing validation protocol development in line with standards. Managing performance of contract resources and overseeing outsourced verification work. Acting as a liaison between engineering and quality assurance during projects. Ensuring safety compliance and proper documentation of work. Reviewing and approving commissioning reports and maintenance practices. Additional activities include leading multidisciplinary teams, supporting process improvements, providing technical support, coaching project teams, defending calibration and validation during inspections, participating in audits, and developing business metrics. Top Must Have Skill Sets: Strong hands-on engineering experience with technical/troubleshooting skills; industry backgrounds include drug substance, pharma, chemical, oil refinery, or mechanical. Ability to troubleshoot GMP manufacturing process equipment and hold technical conversations. Knowledge of SPC, QMS, change control, project management, Lean Six Sigma, SOP/batch record development, cGMP compliance, process development, and validation. Experience with bioprocess development and scale-up. Technical writing skills and experience with tech transfer and training. Basic Qualifications: Doctorate OR Master’s with 3+ years OR Bachelor’s with 5+ years OR associate’s with 10+ years OR high school diploma with 12+ years of engineering/manufacturing experience. Preferred Qualifications: Bachelor's in engineering or related field. 7+ years relevant experience, including 5+ in operations/manufacturing. Experience in regulated environments (FDA, OSHA, EPA). Knowledge of cGMP procedures, process automation, validation, and industry trends. Experience with process equipment, automation systems, and quality systems verification. Strong communication, technical writing, collaboration, and training skills. Proven track record in process improvement methodologies. Why is the Position Open?
To supplement the team’s workload. Red Flags:
Resumes lacking detail, poor communication, leadership, or teamwork. Interview Process:
WebEx Qualified candidates are invited to send their resumes to
resumes@3keyconsulting.com . Visit our website for other opportunities.
#J-18808-Ljbffr
Engineer Senior Technical Support GMP Manufacturing (JP12779) Location:
Thousand Oaks, CA. 91320 Business Unit:
Facilities and Equipment Drug Substance Supply Employment Type:
Contract Duration:
1+ years (with possible extensions) Rate:
$45 - $50/Hr, with benefits Posting Date:
6/24/2024 Notes:
Only qualified candidates need apply. Fully onsite. Standard business hours 3 Key Consulting is hiring! We are recruiting an
Engineer Senior
for a consulting engagement with our client, a leading global biotechnology company. Job Description: Looking for hands-on
strong
engineer experience with proper training/background in technical skills/mathematics. This role is NOT for quality lab, bench top, or science work. Candidates should be practical in troubleshooting and able to hold technical conversations. Transferable industry backgrounds include drug substance, pharma, chemical, oil refinery, or mechanical sectors. This position supports manufacturing activities related to cGMP equipment and facilities at our client’s Thousand Oaks, CA. site. The senior engineer collaborates with automation, maintenance, project management, corporate engineering, and manufacturing teams to develop and oversee equipment operation and reliability, ensuring safety and quality compliance. Responsibilities include supporting department and capital projects, providing data for business cases and strategy, and offering direct technical support. The engineer's key responsibilities include: Modeling leadership behaviors to foster a positive work environment. Ensuring manufacturing equipment reliability and managing key capital projects. Identifying critical quality parameters and process attributes for equipment or facility modifications. Suggesting design modifications for risk mitigation and quality/safety enhancement. Developing commissioning strategies based on URS and QRAES to validate equipment design, minimizing costs and schedule impact. Overseeing validation protocol development in line with standards. Managing performance of contract resources and overseeing outsourced verification work. Acting as a liaison between engineering and quality assurance during projects. Ensuring safety compliance and proper documentation of work. Reviewing and approving commissioning reports and maintenance practices. Additional activities include leading multidisciplinary teams, supporting process improvements, providing technical support, coaching project teams, defending calibration and validation during inspections, participating in audits, and developing business metrics. Top Must Have Skill Sets: Strong hands-on engineering experience with technical/troubleshooting skills; industry backgrounds include drug substance, pharma, chemical, oil refinery, or mechanical. Ability to troubleshoot GMP manufacturing process equipment and hold technical conversations. Knowledge of SPC, QMS, change control, project management, Lean Six Sigma, SOP/batch record development, cGMP compliance, process development, and validation. Experience with bioprocess development and scale-up. Technical writing skills and experience with tech transfer and training. Basic Qualifications: Doctorate OR Master’s with 3+ years OR Bachelor’s with 5+ years OR associate’s with 10+ years OR high school diploma with 12+ years of engineering/manufacturing experience. Preferred Qualifications: Bachelor's in engineering or related field. 7+ years relevant experience, including 5+ in operations/manufacturing. Experience in regulated environments (FDA, OSHA, EPA). Knowledge of cGMP procedures, process automation, validation, and industry trends. Experience with process equipment, automation systems, and quality systems verification. Strong communication, technical writing, collaboration, and training skills. Proven track record in process improvement methodologies. Why is the Position Open?
To supplement the team’s workload. Red Flags:
Resumes lacking detail, poor communication, leadership, or teamwork. Interview Process:
WebEx Qualified candidates are invited to send their resumes to
resumes@3keyconsulting.com . Visit our website for other opportunities.
#J-18808-Ljbffr