Engineer Senior

4 weeks ago

Newbury Park, United States US Tech Solutions Full time

Fully Onsite
Standard business hours

Notes from hiring manager:
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

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks. 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

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

Employee Value Proposition:
Unique industry opportunity, career growth

Interview Process:
WebEx

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability, or status as a protected veteran.

  • Engineer Senior

    1 week ago

    Newbury Park, California, United States US Tech Solutions Full time

    Fully OnsiteStandard business hoursNotes from hiring manager: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...

  • Senior Automation Engineer

    1 month ago

    Newbury Park, United States ATS Automation Full time

    ATS Company: PA Solutions Requisition ID: 11192 Location: Newbury Park, CA, US, 91320 Date: May 16, 2024 Senior Automation Engineer Job Description We engineer a sustainable future Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The...

  • Senior Automation Engineer

    4 weeks ago

    Newbury Park, United States ATS Automation Full time

    ATS Company: PA Solutions Requisition ID: 11192 Location: Newbury Park, CA, US, 91320 Date: May 16, 2024 Senior Automation Engineer Job Description We engineer a sustainable future Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The...

  • Senior Automation Engineer

    2 weeks ago

    Newbury Park, United States ATS Automation Full time

    ATS Company: PA Solutions Requisition ID: 11192 Location: Newbury Park, CA, US, 91320 Date: Jun 14, 2024 Senior Automation Engineer Job Description We engineer a sustainable future Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The...

  • Senior Engineer

    4 weeks ago

    Newbury Park, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Engineer

    4 weeks ago

    Newbury Park, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Automation Engineer

    1 month ago

    Newbury Park, California, United States ATS Automation Full time

    Job DescriptionWe engineer a sustainable future Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The company currently employs more than1,500 people with a global presence in Europe, the Americas, and Asia. Our operational activities focus on...

  • Senior Automation Engineer

    4 weeks ago

    Newbury Park, California, United States ATS Automation Full time

    Job DescriptionWe engineer a sustainable future Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The company currently employs more than1,500 people with a global presence in Europe, the Americas, and Asia. Our operational activities focus on...

  • Senior Engineer

    4 weeks ago

    Newbury Park, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Engineer

    4 weeks ago

    Newbury Park, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Engineer

    3 weeks ago

    Newbury Park, United States US Tech Solutions Full time

    Position Summary:HYBRID 3/4 days onsite, 1-2 remote. USTO. Standard Business hours with some after-hours support on call by manufacturing potentially twice a month for 2-4 hours. *Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).Ideal candidate: 1-2 years of industry experience,...

  • Engineer

    1 week ago

    Newbury Park, California, United States US Tech Solutions Full time

    Position Summary:HYBRID 3/4 days onsite, 1-2 remote. USTO. Standard Business hours with some after-hours support on call by manufacturing potentially twice a month for 2-4 hours. *Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).Ideal candidate: 1-2 years of industry experience,...

  • Senior Scientist

    4 weeks ago

    Newbury Park, California, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Scientist

    1 month ago

    Newbury Park, California, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Engineer

    1 week ago

    Rego Park, New York, United States City of Buffalo, NY Full time

    Location: Parks & Streets- City Hall Room 502, NY Job Type: Full-Time Department: PUBLIC WORKS Division: PUBLIC WORKS GENERAL OFFICE About the Job: Are you looking for a challenging engineering role in the City of Buffalo? We have an exciting opportunity for a Senior Engineer to join our team. As a Senior Engineer, you will perform technical engineering...

  • Senior Electrical Engineer

    2 months ago

    Highland Park, United States Cyfle Full time

    About the job Senior Electrical Engineer We have partnered with a global industrial electrical manufacturing company in Highland, IL area to provide them with a Senior Electrical Engineer. Please review the below description and let us know if you are interested. Prioritized must haves for the Senior Electrical Engineer: #1. BSEE Degree or equivalent.#2. 6...

  • Senior Electrical Engineer

    4 weeks ago

    Highland Park, United States Cyfle Full time

    About the job Senior Electrical Engineer We have partnered with a global industrial electrical manufacturing company in Highland, IL area to provide them with a Senior Electrical Engineer. Please review the below description and let us know if you are interested. Prioritized must haves for the Senior Electrical Engineer: #1. BSEE Degree or equivalent.#2. 6...

  • Senior Electrical Engineer

    2 weeks ago

    Highland Park, United States Cyfle Full time

    About the job Senior Electrical Engineer We have partnered with a global industrial electrical manufacturing company in Highland, IL area to provide them with a Senior Electrical Engineer. Please review the below description and let us know if you are interested. Prioritized must haves for the Senior Electrical Engineer: #1. BSEE Degree or equivalent. #2....

  • Senior Estimator

    1 month ago

    Newbury Park, United States SMITH Mechanical, Electrical & Plumbing Full time

    Job DescriptionGeneral Job Description: The Estimator position will be primarily responsible for providing accurate quotes, training support, assist the sales team in maintaining estimating databases and creating new estimating methods. Supervises: None Essential Duties & Responsibilities: Act as an Estimating Lead of all market types (mainly large-scale...

  • Senior Estimator

    4 weeks ago

    Newbury Park, United States SMITH Mechanical, Electrical & Plumbing Full time

    Job DescriptionGeneral Job Description: The Estimator position will be primarily responsible for providing accurate quotes, training support, assist the sales team in maintaining estimating databases and creating new estimating methods. Supervises: None Essential Duties & Responsibilities: Act as an Estimating Lead of all market types (mainly large-scale...