Senior Engineer, Quality

The Senior 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.

Supports the Quality Engineering group by auditing commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other QA tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

• Implement and maintain the effectiveness of the Quality System.
• Ensure that all quality goals are met and all practices and procedures comply with company policies and applicable regulations.
• Conduct thorough investigations of plant events and document them accurately, including inclusion in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
• Maintain a cooperative liaison with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures; ensure procedures comply with policy and are logical.
• Approve calibration requests and ensure these requests have appropriate product/process limits assigned.
• Audit commissioning and validation documentation.
• Develop product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEAs. Implement statistical quality programs and process monitoring systems.
• For specific U.S. manufacturing sites, perform batch release.

• Bachelor's degree, preferably in Biology, Chemistry or Engineering.
• 6+ years of overall experience in Manufacturing, Quality or Engineering.
• Strong verbal and written communication skills.
• Strong problem‑solving and analytical skills.
• Strong interpersonal relations / communication skills.
• Strong negotiation skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, bulk drug or finished goods manufacturing.

• Experience manufacturing within pharmaceutical, medical device, biotechnology and food industry with cGMP is highly desirable.
• Experience with Risk Management Files including FMEAs is highly desirable.
• Experience with Process Validation and Equipment with ability to validate Large Process Changes, New Products and New Custom Equipment is highly desirable.

• Compensation range 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 a 401(k) plan 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 is allocable to a particular employee and remains in the Company's sole and absolute discretion until paid, and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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  US & Puerto Rico applicants seeking a reasonable accommodation: