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

​​

  • 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. ​​

​​

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. 

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

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Average salary estimate

$80000 / YEARLY (est.)
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$70000K
$90000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Technical Operations Validation Analyst, AbbVie

Join AbbVie as a Technical Operations Validation Analyst in the beautiful city of Waco, TX! At AbbVie, our mission is to discover and deliver innovative medicines and solutions that tackle serious health issues today while preparing for medical challenges of tomorrow. As a Technical Operations Validation Analyst, you'll play a crucial role in developing engineering studies and validation protocols that ensure the safety and efficacy of our products. You'll be getting hands-on experience with temperature mapping and sterilization activities, while also analyzing data and generating insightful reports. This position is perfect for someone who loves problem-solving and thrives in a collaborative environment. We value good communication, so you'll need to share your findings clearly with your team and refer to relevant literature to provide scientific context. With a background in Biology, Chemistry, Engineering, or a related field, coupled with at least two years of experience in validation or quality assurance, you'll find this role to be both rewarding and engaging. Plus, at AbbVie, we are dedicated to enhancing lives across several therapeutic areas such as immunology and oncology. An exciting career awaits you with the opportunity to grow and make a significant impact every day!

Frequently Asked Questions (FAQs) for Technical Operations Validation Analyst Role at AbbVie
What are the primary responsibilities of a Technical Operations Validation Analyst at AbbVie?

As a Technical Operations Validation Analyst at AbbVie, your main responsibilities include creating and developing engineering study protocols, executing validation activities, and performing data analysis for completed requalification studies. You will also plan and manage scheduled activities, ensuring all compliance with corporate standards and safety regulations.

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What qualifications are necessary to apply for the Technical Operations Validation Analyst position at AbbVie?

To apply for the Technical Operations Validation Analyst position at AbbVie, you ideally need a Bachelor's Degree in Biology, Chemistry, Engineering, or a closely related discipline, along with at least two years of experience in Validation, Manufacturing, or Quality roles. Strong communication and analytical skills are also essential for success in this role.

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What skills are advantageous for a Technical Operations Validation Analyst at AbbVie?

As a Technical Operations Validation Analyst at AbbVie, having strong analytical and problem-solving skills is advantageous. Familiarity with steam sterilization, autoclave validation, and previous experience in manufacturing processes will provide a significant advantage. Additionally, good interpersonal communication skills and the ability to negotiate effectively are important for collaborating with team members and stakeholders.

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What does a typical day look like for a Technical Operations Validation Analyst at AbbVie?

A typical day for a Technical Operations Validation Analyst at AbbVie involves executing validation studies, analyzing data, and preparing reports. You will be collaborating with cross-functional teams to ensure compliance with GxP standards, managing documentation, and possibly setting up temperature sensors for qualification activities. Every day offers a chance to make a meaningful impact in the field of healthcare.

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What is AbbVie’s approach to diversity and inclusion in hiring Technical Operations Validation Analysts?

AbbVie is committed to creating a diverse and inclusive work environment. In hiring Technical Operations Validation Analysts, the company focuses on attracting qualified candidates from various backgrounds, without discrimination based on race, gender, age, or other protected statuses. AbbVie values the unique perspectives individuals bring, contributing to innovation and excellence within the team.

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Common Interview Questions for Technical Operations Validation Analyst
Can you describe your experience with validation processes?

In answering this question, share specific examples from your previous roles, emphasizing your familiarity with validation protocols and methodologies. Discuss how you've contributed to successful validation projects and any challenges you overcame.

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How do you stay updated on industry regulations and standards?

Discuss your methods for staying informed, such as attending workshops, reading industry publications, or participating in professional organizations relevant to validation and compliance in the pharmaceutical industry.

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What tools or software do you use for data analysis in validation?

Explain your proficiency with data analysis tools and software. Mention specific programs you are familiar with, and discuss how you utilize these tools to analyze validation data effectively.

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How would you handle discrepancies found during validation studies?

Illustrate your problem-solving approach. Emphasize the importance of documentation, team collaboration, and following through with corrective actions to resolve discrepancies diligently and effectively.

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What is your understanding of GxP compliance?

Provide a solid definition of Good Practice (GxP) compliance as it relates to pharmaceutical operations. Avoid jargon; instead, focus on explaining the principles and their importance in ensuring quality and safety.

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Describe a challenging project you worked on and how you managed it.

Highlight a specific project, detailing the challenges, your role in addressing them, and the successful outcomes achieved. Mention any lessons learned and how this experience has equipped you for future projects.

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How do you prioritize tasks during busy validation periods?

Discuss your time management strategies, including how you assess the urgency and importance of tasks, delegate when necessary, and use project management tools to stay organized.

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How do you ensure accuracy in your validation reports?

Emphasize your attention to detail, review processes, and the use of double-checking methods. Explain how clear documentation practices contribute to report accuracy.

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What do you believe sets AbbVie apart from other companies in the industry?

Demonstrate your knowledge of AbbVie’s mission and values. Highlight specific aspects that resonate with you, such as its commitment to innovation, patient focus, and community service.

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Why do you want to work at AbbVie as a Technical Operations Validation Analyst?

Express your enthusiasm for AbbVie’s mission and values. Discuss how the Technical Operations Validation Analyst role aligns with your career goals and how you can contribute to the company's success.

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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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April 4, 2025

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