Engineer

3 weeks ago


Thousand Oaks, United States Crystal Equation Corporation Full time

Engineer


Summary:

The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in technical writing, developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.


This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.


The chosen candidate will sometimes spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems.


This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.


Responsibilities:

  • (55%) Technical authorship of test protocols and reports to support characterization and verification activities. Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
  • (25%) Hands on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices. Testing of autoinjector devices, including the safe operation of test equipment
  • (20%) Statistical data analysis of test results to be included in technical reports.



Top 3 Must Have Skill Sets:

  1. Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
  2. Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
  3. Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.



Basic Qualifications:

  • Master’s degree

OR

  • Bachelor’s degree and 2 years of experience

OR

  • Associate’s degree and 6 years of experience

OR

  • High school diploma / GED and 8 years of experience



Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.



THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.


  • Engineer

    4 days ago


    Thousand Oaks, United States Crystal Equation Corporation Full time

    Engineer*Onsite in Thousand Oaks, CA* Top 3 Must Have Skill Sets:Troubleshooting skillsMechanical systems expertiseAbility to analyze problems, develop and propose engineering solutions in a scientific mannerSummary:The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at our company. The...

  • Engineer

    3 weeks ago


    Thousand Oaks, United States US Tech Solutions Full time

    Position Summary: Title: Engineer (Process Development) Location : Thousand Oaks, CA (Hybrid) Duration : - Months (End date - //; Possible Extension)  Tax term: W HYBRID / days onsite, - remote. USTO. Standard Business hours with some after-hours support on call by manufacturing potentially twice a month for - hours. Candidate will...

  • Engineer

    3 weeks ago


    Thousand Oaks, United States US Tech Solutions Full time

    Position Summary: Title: Engineer (Process Development) Location : Thousand Oaks, CA (Hybrid) Duration : 11-12 Months (End date - 05/19/2025; Possible Extension) Tax term: W2 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...

  • Engineer Senior

    3 days ago


    Thousand Oaks, United States Crystal Equation Full time

    Engineer Senior Top 3 Must Have Skill Sets: Background in Single Use Technologies Background in Process Engineering Project management skills Validation experience Red Flags: Poor communication HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degre Engineer, Process Engineer, Operations, Senior, Leadership, Equipment, Staffing

  • Engineer

    3 days ago


    Thousand Oaks, United States SSI People Full time

    Title: Engineer Location: Thousand Oaks, CA (Onsite) Contract Pay rate: $42/hr Skills required are: Troubleshooting skills Mechanical systems expertise Ability to analyze problems, develop and propose engineering solutions in a scientific manner Responsibilities: Ownership of processing equipment ( establishing and maintaining maintenance strategy) provide...

  • Engineer

    4 days ago


    Thousand Oaks, United States SSi People Full time

    Title: EngineerLocation: Thousand Oaks, CA (Onsite)ContractPay rate: $42/hrSkills required are:Troubleshooting skillsMechanical systems expertiseAbility to analyze problems, develop and propose engineering solutions in a scientific mannerResponsibilities:Ownership of processing equipment ( establishing and maintaining maintenance strategy)provide Support for...

  • Engineer

    3 days ago


    Thousand Oaks, United States SSi People Full time

    Title: EngineerLocation: Thousand Oaks, CA (Onsite)ContractPay rate: $42/hrSkills required are:Troubleshooting skillsMechanical systems expertiseAbility to analyze problems, develop and propose engineering solutions in a scientific mannerResponsibilities:Ownership of processing equipment ( establishing and maintaining maintenance strategy)provide Support for...

  • Validation Engineer

    3 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior Engineer Location: Thousand Oaks, CA Duration: 12 Months Description: Onsite - 100% Thousand Oaks, CA NO RELOCATION CANDIDATES LOCATION ON THE RESUMES Must be available for potential on call for Overtime looking at potentially 10-12 hours a month. Top 3 Must Have Skill Sets: Demonstrated strong communication and technical writing skills...

  • Validation Engineer

    4 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    4 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    4 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    3 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior Engineer Location: Thousand Oaks, CA Duration: 12 Months Check below to see if you have what is needed for this opportunity, and if so, make an application asap. Description: Onsite - 100% Thousand Oaks, CA NO RELOCATION CANDIDATES LOCATION ON THE RESUMES Must be available for potential on call for Overtime looking at potentially 10-12...


  • Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/Equipment Location: Thousand Oaks, CA Duration: 12 Months Description: Onsite - 100% Thousand Oaks, CA Top 3 Must Have Skill Sets: Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership) Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting...


  • Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/EquipmentLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CATop 3 Must Have Skill Sets:• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting...

  • Process Engineer

    3 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer Location: Thousand Oaks, CADuration: 12+ MonthsOnsite - 100% Thousand Oaks, CADescription:Must be available for potential on call for Overtime looking at potentially 10-12 hours a month.This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will...

  • Process Engineer

    3 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer Location: Thousand Oaks, CADuration: 12+ MonthsOnsite - 100% Thousand Oaks, CADescription:Must be available for potential on call for Overtime looking at potentially 10-12 hours a month.This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will...


  • Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/EquipmentLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CATop 3 Must Have Skill Sets:• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting...


  • Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/Equipment Location: Thousand Oaks, CA Duration: 12 Months Considering making an application for this job Check all the details in this job description, and then click on Apply. Description: Onsite - 100% Thousand Oaks, CA Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with cross...

  • Engineer-Autoclaves

    4 days ago


    Thousand Oaks, United States Infotree Global Solutions Full time

    ONSITE THOUSAND OAKSFlexible availability, schedule is 7am - 4pm need to be open to after hours calls.Ideal candidate: Highly motivated individual, system owner Mechanical and electrical engineering background. Pharmaceutical industry manufacturing maintenance engineering and not operations side. Direct knowledge of design and troubleshooting with GMP...

  • Process Engineer

    4 weeks ago


    Thousand Oaks, United States ACL Digital Full time

    Title: EngineerLocation: Thousand Oaks, CADuration: 12 + months contractThis engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee...