Validation Engineer

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  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include: the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, participation in the establishment of plant quality systems, supporting regulatory and third party audits.

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the 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.
• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• Prefer 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
• Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.
  
  Individual compensation paid within this range will depend on many factors including geographic location, andwemay ultimately pay more or less than the posted range. This range may be modified in thefuture.

• 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 payis considered to bewages 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 andabsolutediscretion unless and until paid andmay 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.

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