Current jobs related to Engineer Senior - Thousand Oaks - US Tech Solutions
-
Senior Engineer
2 weeks ago
Thousand Oaks, United States ACL Digital Full timeDescription:Thousand Oaks, CA - 80% in personIdeal Candidate: B.S. 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA.Nice to have: Minitab and Pharma or med device background.Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer...
-
Senior Project Engineer
2 weeks ago
Thousand Oaks, United States ACL Digital Full timeTitle: Senior Engineer Location: Thousand Oaks, CA Duration: 12 months contract Ideal Candidate: B.S. 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA.Nice to have: Minitab and Pharma or med device background.Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle...
-
Senior Project Engineer
2 weeks ago
Thousand Oaks, United States ACL Digital Full timeTitle: Senior Engineer Location: Thousand Oaks, CA Duration: 12 months contract Ideal Candidate: B.S. 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA.Nice to have: Minitab and Pharma or med device background.Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle...
-
Engineer Senior
5 days ago
Thousand Oaks, United States ACL Digital Full timeFully onsite at Thousand Oaks, CA Standard business hours Scrubbed resume attached- looking for Engineer experience in a pharma manufacturing setting** Copy of AMAGJP00012779 Feedback from mgr: Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science...
-
Senior Engineer
2 weeks ago
Thousand Oaks, United States Discover International Full timeJob Title: Senior Engineer – Medical Device DevelopmentLocation: Thousand Oaks, CA (80% On-Site)Employment Type: Contract (Possible Extension)*ONLY ABLE TO ACCEPT W2 CANDIDATES AT THIS TIME, NO C2C!*Position Overview:We are seeking a skilled Senior Engineer with a strong background in mechanical or electro-mechanical engineering to lead the development of...
-
Senior Engineer
2 weeks ago
Thousand Oaks, United States Discover International Full timeJob Title: Senior Engineer – Medical Device DevelopmentLocation: Thousand Oaks, CA (80% On-Site)Employment Type: Contract (Possible Extension)*ONLY ABLE TO ACCEPT W2 CANDIDATES AT THIS TIME, NO C2C!*Position Overview:We are seeking a skilled Senior Engineer with a strong background in mechanical or electro-mechanical engineering to lead the development of...
-
Senior Engineer
2 weeks ago
Thousand Oaks, United States Amgen Full timeJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four...
-
Senior Engineer/CAPA/Investigation
2 weeks ago
Thousand Oaks, United States ACL Digital Full timeJob Title: Senior Engineer Location: Thousand Oaks CADuration: 1 year contractNO C2CDescription:Thousand Oaks, CA - 80% in personIdeal Candidate: B.S. 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA.Nice to have: Minitab and Pharma or med device background.Top 3 Must Have Skill Sets:1. Previous experience in medical...
-
Senior Engineer/CAPA/Investigation
2 weeks ago
Thousand Oaks, United States ACL Digital Full timeJob Title: Senior Engineer Location: Thousand Oaks CADuration: 1 year contractNO C2CDescription:Thousand Oaks, CA - 80% in personIdeal Candidate: B.S. 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA.Nice to have: Minitab and Pharma or med device background.Top 3 Must Have Skill Sets:1. Previous experience in medical...
-
Senior Engineering Leader
14 hours ago
Thousand Oaks, California, United States Crystal Equation Corporation Full timeCareer opportunities are available at Crystal Equation Corporation for an experienced Senior Engineering Leader to join our Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team. As a key member of this team, you will be responsible for supporting Clinical & Commercial Plant Automation Programs and Capital Projects for ATO...
-
Senior Engineer
5 days ago
Thousand Oaks, United States Aditi Consulting Full timeSummary: This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). 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...
-
Senior Engineer
1 week ago
Thousand Oaks, United States Amgen Full timeAmgen Senior Engineer Thousand Oaks, California Apply NowJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the...
-
Senior Quality Engineer
5 days ago
Thousand Oaks, United States Addman Engineering Full timeJob Type Full-time Description POSITION SUMMARY: The Senior Quality Engineer- Lead will be responsible for leading the quality assurance team in the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in alignment with AS9100 standards. The Senior Quality Engineer will work closely with cross-functional teams,...
-
Senior Manufacturing Systems Engineer
6 days ago
Thousand Oaks, United States Amgen SA Full timeHOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. At Amgen, our shared mission—to serve patients—drives all that we do. Come do your best work alongside other innovative, driven professionals in this meaningful role.Senior Manufacturing Systems EngineerWhat...
-
Reliability Engineer
6 days ago
Thousand Oaks, United States ACL Digital Full timeJob Title: Senior Engineer/Reliability EngineerLocation: Thousand Oaks CADuration: 12 MonthsDescription:Top 3 Must Have Skill Sets: • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and...
-
Reliability Engineer
6 days ago
Thousand Oaks, United States ACL Digital Full timeJob Title: Senior Engineer/Reliability EngineerLocation: Thousand Oaks CADuration: 12 MonthsDescription:Top 3 Must Have Skill Sets: • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and...
-
Senior Automation Engineer
6 days ago
Thousand Oaks, United States ACL Digital Full timeEngineer Principal (AMAGJP00013312)3 years contractFully onsite Thousand Oaks, CAseeking a professional Principal Automation Engineer for employment. As a member of the Amgen Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, the successful candidate will be required to support Clinical & Commercial Plant Automation...
-
Senior Automation Engineer
6 days ago
Thousand Oaks, United States ACL Digital Full timeEngineer Principal (AMAGJP00013312)3 years contractFully onsite Thousand Oaks, CAseeking a professional Principal Automation Engineer for employment. As a member of the Amgen Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, the successful candidate will be required to support Clinical & Commercial Plant Automation...
-
Senior Automation Engineer
3 days ago
Thousand Oaks, United States ACL Digital Full timeEngineer Principal (AMAGJP00013312)3 years contractFully onsite Thousand Oaks, CAseeking a professional Principal Automation Engineer for employment. As a member of the Amgen Manufacturing & Clinical Supply (MCS) - Facilities & Engineering (F&E) Automation team, the successful candidate will be required to support Clinical & Commercial Plant Automation...
-
Equipment Engineer
6 days ago
Thousand Oaks, United States ACL Digital Full timeSenior EngineerThousand Oaks, CA12 months contract Seeking resumes with process equipment experience This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and...
Engineer Senior
2 weeks ago
Looking for hands on *strong* engineer experience with proper training/ background in technical side/ mathematics. *Not looking* for quality lab/ bench top/ science work. The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation. (Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical)
Resumes need to have a strong level of detail that documents the job seekers experience. Job seekers must be able to speak to the experience listed in interview
Must have engineering degree
Description
Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation.
Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). 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.
The Senior Engineer role will provide direct engineering technical support as follows:
• 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
• Review and approve the commissioning reports, maintenance practices and parts, and drive productivity improvement
Related Activities:
• Participate or lead, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
• Provide ad hoc technical support and guidance for manufacturing and maintenance
• Provide coaching and guidance to project teams and engineers using risk-based approaches
• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
• Participate in internal audits and assess in conjunction with quality assurance
• Assist in developing and maintaining business metric performance
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 OR Associate's degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 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
• Understanding and awareness of industry/regulatory trends for verification/validation
• Experience with combination product / medical device quality systems verification
• Strong process equipment knowledge - cell culture, fermentation, purification, filling, and packaging
• Strong process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.
o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Interview Process:
WebEx