Engineer, Quality

NCSL International; Tempe (AZ); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

401(k)

Job summary

AbbVie is seeking a Quality Engineer for its Tempe, AZ manufacturing facility to lead Manufacturing Quality Assurance activities, including deviation resolution, CAPA execution, and regulatory compliance. The role covers SOP governance, calibration oversight, and quality improvement initiatives across the plant.

You will collaborate with Validation and Plant teams to ensure cGMP adherence and alignment with Abbott policies, applying strong problem solving and communication skills daily.

Qualifications

• Bachelor's degree required in Biology, Chemistry, Engineering or related field.
• 2+ years of experience in Manufacturing, Quality, or Engineering.
• Strong verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal and negotiation skills.
• Knowledge of quality/compliance management and regulatory standards for API/Bulk/Finished goods manufacturing.

Responsibilities

• Assist in validation and certification of new process equipment and review certified systems for QA readiness.
• Maintain and improve the Quality System and ensure adherence to policies and regulations.
• Support quality goals and ensure practices and procedures comply with company policies and applicable regulations.
• Ensure investigations of plant events are thorough, documented, and included in the CAPA system; perform product impact analyses and QA holds when needed.
• Maintain liaison with other Quality areas and Plant departments to ensure alignment.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve SOPs and calibration requests with appropriate product/process limits.
• Develop and implement statistical quality programs and ensure acceptance sampling meets product quality confidence levels.

Skills

Verbal and written communication

Problem solving

Interpersonal relations

Negotiation skills

Quality/compliance management

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

ICompany Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

Responsibilities

• Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience
• 2+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

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 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI