Engineer, Quality, 3rd shift

Join to apply for the Engineer, Quality, 3rd shift (Monday-Friday, 11 PM-7:30 PM) role at Bio Space

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address medical challenges of tomorrow. The company aims to impact people’s lives across key therapeutic areas including immunology, oncology, neuroscience, and ophthalmology and through its Allergan Aesthetics portfolio. For more information, visit Abb Vie.

Job Description

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant, including resolution of deviations, product impact analysis, corrective and preventive actions, investigations, SOP approval, calibration program oversight, and quality improvement initiatives, ensuring cGMP and Abbott policy compliance. The role supports the Quality Engineering group by auditing commissioning and validation documentation, authoring qualification protocols, reviewing planned maintenance, and performing additional QA tasks as assigned by the MQA Section Manager or Plant QA Manager.

The purpose is to ensure the plant is GMP ready.

• Implement and maintain the effectiveness of the Quality System within the manufacturing building, working a blend of desk and production floor.
• Ensure all quality goals are met and that practices comply with company policies and applicable regulations.
• Complete thorough investigations of plant events, document them accurately, and include them in the plant CAPA system; perform product impact analyses and place product on QA hold when necessary.
• Maintain effective liaison and cooperative relationships with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures, ensuring compliance with policy and clarity.
• Approve calibration requests and ensure appropriate product/process limits are assigned.
• Audit commissioning and validation documentation.
• Develop product quality plans, specifications, 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.
• GMP experience required; experience in Pharmaceutical Manufacturing preferred.
• Good verbal and written communication skills.
• Strong problem‑solving and analytical skills.
• Effective interpersonal and negotiation skills.
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug, or Finished Goods manufacturing.
• Availability during shift hours on Saturdays and Sundays.

• The compensation range is the range of possible base pay that Bio Space believes in good faith it will pay for this role at the time of posting. Individual compensation will depend on many factors including geographic location.
• Bio Space offers a comprehensive benefits package that includes paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan for eligible employees.
• This role is eligible for short‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to integrity, innovation, and community service. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico applicants seeking a reasonable accommodation can learn more online.