Aseptic Lead

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.

Purpose

The Aseptic Lead ensures that procedures related to Aseptic (including Process Hygiene site) manufacturing are in compliance with relevant regulatory requirements and network best practices. Partners with site colleagues and other members of the Site Aseptic team, to create an environment with the highest standards of Aseptic Manufacturing. Drives continuous improvement in aseptic manufacturing on site.

Responsibilities

• Ensures that operations procedures required for Aseptic / Process Hygiene Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
• Drives a high-performance culture in Aseptic Manufacturing, through robust interventions, well planned communication and colleague engagement.
• Actively leads and/or provides subject matter expertise to investigations of process/product issues in support of bioburden contamination, sterility, media fill, environmental monitoring excursions and assists with establishing root cause and CAPA.
• Performs analysis and trending of Environmental Monitoring (EM) data (Facility and Personnel) including ownership of the EM Visualization tool and develops and executes action plans to address EM trends. Owns the Site Contamination Control Strategy. Responsible for periodic review and update as per regulations.
• Drives continuous improvement of Aseptic / Process Hygiene Manufacturing procedures through assessment, interpretation and application of new regulations to site operations in a timely manner. Implements best practices in Aseptic / Process Hygiene Manufacturing.
• Assess the Aseptic technique and behavior of the operating and laboratory teams, provides feedback as appropriate and implements actions as needed, in particular, during critical aseptic activities such as cleaning, sanitization, aseptic set-up, EM plate handling, sampling, testing and Interventions.
• Provides thoughtful and relevant input into Cleanroom/ Equipment/ Utility design, Qualification and Re-Qualification processes, Preventative Maintenance strategies and real-time monitoring.
• Completes pFMEA and What If/ HAZOP assessments.
• Participates in regulatory audits as Aseptic subject matter expert.

• Bachelor’s degree in Microbiology, Biology or Science, and 7+ Years of experience in operations with emphasis in aseptic process, quality/regulatory in pharma, biologics, or equivalent regulated industry
• Experience in microbiology lab.
• Demonstrated leadership skills including strategic planning, project management and implementation.
• Demonstrated knowledge in Quality Systems, Quality Operations practices, and procedures.
• Basic statistical tools knowledge
• Ability to make decisions with minimum oversight

Key Stakeholders 

Business Title:

• Aseptic Operations Lead

• Aseptic Quality Lead

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. ​

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