*Operations Associate III

About AbbVie
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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. AbbVie is always striving to find top scientists/associates to work at our Campbell site. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!

Operations Analyst III- Biopharmaceutical/GMP

An "ideal" candidate for this role is someone with sound knowledge of the biopharmaceutical manufacturing environment with hands on experience in fermentation and purification and experience in regulatory requirements.

Successful candidates will have the following types of experience:

• The manufacture of marketed drug substance
• Implementing improvements to the equipment, procedures and systems used in Manufacturing
• Support of ongoing clinical products and projects related to new product introduction and technical transfer

YOU WILL:

Be a trusted and expert partner. Technical expertise should include thorough knowledge of biopharmaceutical manufacturing technology and regulatory requirements, normally acquired through a progressive operation experience in a GMP environment. Especially critical is high level knowledge and experience in the areas of microbiology, fermentation, aseptic processing, and protein purification techniques.

Be a compliance expert. Completion and review of Manufacturing documentation. This includes forms, batch production records and any other quality system documentations. You will improve the technical capabilities and quality practices within the department. Coordinate activities and resolve issues across the department, other groups, and/or projects. You will respond to and/or resolve recurring technical or processing issues. Develop and implement novel approaches to solving non-routine technical problems. Communicate information effectively through updates, reports, and summaries. You will lead improvements in processes and methods that reinforce cGMP within the department and/or across the site.

Innovate for the future. Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems. You will conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills. You will provide training and guidance to the staff to meet the goals of the department. When appropriate, assist in providing leadership on project teams. The position will need to be experienced in project management oversight including overseeing the capital expenditure projects and function as a project manager.

Qualifications

YOU BRING:

• BS in Science or Engineering field or Associate's Degree and equivalent years of experience
• Three years working in a GMP environment, Pharmaceutical industry preferred
• Two years of hands on experience of fermentation, purification or pharmaceutical manufacturing process
• Thorough knowledge of biopharmaceutical manufacturing technology and regulatory requirements,
• Previous experience in facility or systems modification / design, as well as specifying equipment, creating systems and Standard Operating Procedures (SOPs)

PDN2

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.