Senior Engineer, Quality
AbbVie
June 27, 2026
On-site
Branchburg, NJ
$84,500 - $162,000 USD yearly
Operations
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant, including resolution of deviations, 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 ensuring cGMP and Abbott policy compliance.
Supports the Quality Engineering group by auditing commissioning and validation documentation completed by others, authoring and executing newly identified qualification/validation protocols, reviewing and approving critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or Plant QA Manager.
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Ensure plant event investigations are thorough, accurately documented, and included in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
- Maintain 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 compliance and clarity.
- Approve calibration requests and ensure appropriate product/process limits.
- Audit commissioning and validation documentation.
- Develop product quality plans/systems (specifications, plans, risk analyses, FMEAs), statistical quality programs, and process monitoring.
- For specific U.S. manufacturing sites, perform batch release.
Qualifications:
- Bachelor’s degree (preferably Biology, Chemistry, or Engineering).
- 6+ years in Manufacturing, Quality, or Engineering.
- Good verbal and written communication.
- Strong problem solving and analytical skills.
- Interpersonal/communication and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing.
Preferred:
- cGMP manufacturing experience in pharmaceuticals/medical devices/biotech/food.
- Risk Management Files including FMEAs.
- Process Validation and equipment experience; ability to validate large process changes, new products, and new custom equipment.
Supports the Quality Engineering group by auditing commissioning and validation documentation completed by others, authoring and executing newly identified qualification/validation protocols, reviewing and approving critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or Plant QA Manager.
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Ensure plant event investigations are thorough, accurately documented, and included in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
- Maintain 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 compliance and clarity.
- Approve calibration requests and ensure appropriate product/process limits.
- Audit commissioning and validation documentation.
- Develop product quality plans/systems (specifications, plans, risk analyses, FMEAs), statistical quality programs, and process monitoring.
- For specific U.S. manufacturing sites, perform batch release.
Qualifications:
- Bachelor’s degree (preferably Biology, Chemistry, or Engineering).
- 6+ years in Manufacturing, Quality, or Engineering.
- Good verbal and written communication.
- Strong problem solving and analytical skills.
- Interpersonal/communication and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing.
Preferred:
- cGMP manufacturing experience in pharmaceuticals/medical devices/biotech/food.
- Risk Management Files including FMEAs.
- Process Validation and equipment experience; ability to validate large process changes, new products, and new custom equipment.