Engineering Analyst, Facilities

Company: Disability Solutions
Location: Irvine
Posted on: March 21, 2023

Job Description:

Overview This position performs as Facilities Engineering investigator and technical writer, with responsibilities around Maintenance & Calibration related issues and their impact on manufacturing, processes, and equipment system at the Bioscience Laboratories in the Irvine, CA facility.Responsibilities

• Investigation of events within the Facilities Engineering dept. relating to Maintenance and Calibration programs, equipment & utilities systems.
• Support Change Control activities, technical writing of TrackWise records such as deviation investigations, CAPA's, risk assessments, change controls, action items, in addition to other compliance reports and/or responses to internal & external audits observations as necessary.
• Assist with the vendor qualification programs, assuring quality and service agreements for Facilities vendors are in place.
• Revise department procedures / SOP's as necessary and as directed by the Facilities Manager.
• Work with other stakeholders and Quality Assurance to determine effective Corrective and Preventive Actions.
• Outline process improvements to increase quality, efficiency, and compliance.
• Support internal / external audits for Facilities Engineering department; coordinate observations responses accordingly.
• Work with training department and assist with department training requirements as necessary.
• Perform other duties as assigned. Incumbent must be self-directing and has full authority to make decisions and/or take action that is required to carry out job duties. AbbVie internal requirements include compliance with ethics, environmental health and safety, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required. Qualifications
  • Bachelor's degree in Engineering or Sciences, or equivalent experience such as a minimum of 5 years of experience in Facilities/Engineering/Maintenance/Calibration field in GMP environment.
  • Minimum five (5) years' experience within pharmaceutical environment; Facilities Engineering, Change Control management / QA experience is preferred.
  • Proficient in Microsoft Office Suite.
  • Familiarity with Change Control management and TrackWise system (or similar system). Essential Knowledge, Skills & Abilities
    • Experience within GMP pharmaceutical environment in Facilities Engineering / Technical / Utilities areas.
    • Change Control management, technical writing of TrackWise records such as deviation investigations, CAPA's, Risk Assessments, Change Controls and Action items.
    • Broad understanding of Maintenance and Calibration activities in GMP / regulated Manufacturing environments.
    • Demonstrated ability in technical writing and problem solving.
    • Broad understanding of department procedures / SOP's.
    • Detail orientated, ability to generate results.
    • Effective communication, verbal and in writing.
    • Ability to obtain gowning access to the controlled area. Applicable to California Applicants Only
      • The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
        • The salary range is (minimum: $55,750 to maximum: $109,000)
        • This job is eligible to participate in our short-term incentive program
        • This job is eligible to participate in our long-term incentive programs
          • We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
            • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Travel: NoJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $55,750 Maximum Salary $109,000

Keywords: Disability Solutions, Irvine , Engineering Analyst, Facilities, Engineering , Irvine, California