Company Description

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

The Technical Operations Validation Engineer is responsible for planning and overall completion of scheduled validation/Requalification activities of Technical Operations department for the Waco Site. Responsibilities may also include executing special validation projects. Under the direction of the Requalification Technical Operations Manager, this individual will participate in planning and overall completion of the Validation Master Plan scheduled activities under minimal supervision. The individual would serve as an individual contributor and the level of responsibility and performance is commensurate with grade level.

Responsibilities:

• Create or develop Engineering study, Developmental and Performance Qualification Protocols for validation or requalification studies.
• Create or develop Final Reports of completed for validation or requalification studies.
• Planning and overall completion of scheduled validation/Requalification activities
• Execution of Temperature Mapping and Sterilization related requalification activities including set-up of temperature sensors and biological samples for qualification.
• Set-up of temperature sensors and biological samples for qualification, perform, peer-review of requalification activities, analysis and calculation of thermometric data using Microsoft Excel including the creation of graphs and trends
• Execution of Periodic Reviews
• Collaborate with other departments to resolve investigations and implement preventive and corrective actions

• Authoring or review standard operating procedures (SOP).

Qualifications

• Bachelor's Degree in Biology, Chemistry, or Engineering or closely related discipline is preferred, or equivalent technical experience plus demonstrated competence
• 2+ years of overall experience in Validation, Manufacturing, Quality or Engineering preferred
• Good verbal and written communication skills
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of Steam Sterilization, Autoclave Load or VHP Sterilization Validation as well as regulations and standards affecting sterility assurance preferred
• Bulk Drug or Finished goods and compounding manufacturing experience is welcomed

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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 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 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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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 and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html