R&D Senior Quality Specialist (Validation),

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Key Responsibilities

• Support the qualification and requalification of equipment and instrumentation, including computerized systems, used within the R&D laboratory function associated with FDA Good Manufacturing Practices (GMP) testing for biological and small molecule projects.
• Responsible for the planning, design and implementation of validation projects, coordination of validation activities, and preparation of validation documentation within Pharmaceutical Development, with established guidelines for pharmaceutical products manufactured in a GMP environment.
• Utilize knowledge of GMP concepts relating to Pharmaceutical manufacturing environment to plan, develop, organize, and execute validation activities applicable to area of technical expertise in accordance with GMP, ISO 9000, ICH, and applicable guidelines including project management, validation documentation generation, and project tracking.
• Maintain project deadlines and communicate validation activities with appropriate personnel in a timely manner.
• Define, author, organize, and review validation documentation, SOPs, and forms.

Education & Experience

Must possess a Bachelors in Engineering, Microbiology or Chemistry, or a related field, and at least 5 years of work experience performing GMP validation. Of experience required, must have 3 years of work experience:

1. Performing laboratory instrumentation validation, temperature mapping of environmental chambers, & sterilization validation (autoclaves);

1. Project coordination involving third-party validation vendor management;

1. Utilizing validation principles and techniques including validation of pharmaceutical processes, facilities/utilities, manufacturing &  laboratory equipment; &

1. Applying GMP concepts relating to pharmaceutical manufacturing environment & validation activities.

Experience must be gained concurrently.

Salary Range: $124,920.26 - $157,500.00 per year

Apply online at https://careers.abbvie.com/en or send resume to [email protected].. Refer to Req ID: REF35111G. 

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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 and long-term incentive programs.

AbbVie 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.

AbbVie 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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