Technical Operations Validation Analyst

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

• 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 independently including set-up of temperature sensors and biological samples for qualification.
• Perform data analysis independently for all executed requalification and generate results
• Place data in proper scientific context by consulting and citing relevant literature.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

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 applyi