Manufacturing Quality Validation Sr. Specialist

Company Description

Abb Vie'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 Abb Vie, please visit us at

The primary responsibility for the Quality Validation Specialist is the quality oversight and overall approval of validation and engineering change management activities. The Validation Engineering department will support the implementation of the Validation quality program and will be expected to independently manage 5+ key projects simultaneously.

• Participate in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensure that all practices and procedures comply with company policies and applicable regulations for the Quality areas under responsibility.
• Execute tasks required to implement the Validation Master Plan and maintain validated state of equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments, and analytical methods to demonstrate that product will perform consistently as intended.
• Ensure investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Participate with plant and external engineering resources on new installations/systems to ensure factory/site/commissioning documentation is in accordance with cGMP and supports validation.
• May supervise contract validation resources in the timely completion of activities in area of responsibility.
• May lead, author, or review investigations and implementation of preventive and corrective action.

• Bachelor's Degree required (preferably in Biology, Chemistry, or Engineering).
• 6+ years of overall experience in Manufacturing and/or Packaging, Quality, or Engineering including 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process, etc.) preferred.
• Strong verbal and written communication skills.
• Solid problem‑solving and analytical skills.
• Solid interpersonal skills, including ability to negotiate/influence without authority.
• Ability to manage complex projects and multiple projects (5+) simultaneously.
• Knowledge of quality/compliance management as well as regulations and standards affecting API, Bulk Drug, or Finished goods manufacturing preferred.

• Various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology.

• 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 may ultimately be paid 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.

• This job is eligible to participate in our long‑term incentive programs.

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.

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