Technical Engineer

3 weeks ago

Irvine, United States AbbVie Full time
Job DescriptionJob DescriptionCompany Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

The individual will provide scientific and technical support as an SME for process engineering and manufacturing technologies.

The role will collaborate with teams from Manufacturing, Quality, Compliance, S&T, and R&D functions to ensure a high degree of GMP compliance, manufacturing operations, data trending, process optimization, investigations, gap & risk assessments, problem-solving, and knowledge transfer.

The individual will provide technical oversight for implementing manufacturing systems, including evaluation, procurement and implementation, design, GMP documentation, technical writing, validation activities, qualification, technology, and knowledge transfer.
 

  • Provide technical and scientific support, subject matter expertise on commercial and clinical manufacturing support, technology transfers, complex deviations, technical troubleshooting, CAPA design, process monitoring, change control, and optimization
  • Support gap assessments, risk assessments, qualification, and validation activities, ensuring the technology is optimally compatible with desired operational processes and GMP requirements. 
  • Support investigations on process abnormalities as well as recommend corrective and preventative actions
  • Lead data analysis of process data statistics, data visualization, data mining, design of experiments, identifying process deviations, assessing product impact, and preparing technical reports while proposing solutions and improvements.
  • Manage cross-functional assignments, including the evaluation, procurement, and implementation of manufacturing systems and equipment, design, GMP documentation, technical writing, qualification, technology, and knowledge transfer.

Work safely and observe all general plant and department safety policies to help achieve environmental, health, and safety goals.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.

Qualifications

  • Excellent knowledge and skills in biopharmaceutical and process engineering.
  • Deep understanding of cGMP’s requirements
  • Must be organized and capable of managing tasks on multiple, concurrent services or projects.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the organization.
  • Education: Chemical Engineering or relevant Science major
  • Previous Experience – 3 to 5 years of relevant experience


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

​

Note: No amount of pay is a 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 and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  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 protected veteran, or any other legally protected group status.

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