Validation Specialist

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

Validation Specialist, Validation - Irvine, CA

The Validation Specialist will be responsible for supporting the development and maintenance of the validation program within Drug Substance Operations (DSO) at the BLI Facility, in accordance with company standards, health authority regulations, cGMP, and emerging trends within industry.

What your manager wants you to know:

AbbVie is always striving to find top engineers to work at our Irvine, CA site. Be Bold and grow your biopharmaceutical career with the pharmaceutical and medical device industry leader!

We are looking for an experienced validation engineer and inspirational leader who is energetic and dependable to add to our group. If you are quality-focused, team-oriented, and care about safety, improvements, and being your best, we would be very interested in receiving your resume.

YOU WILL:

• Support the implementation and maintenance of validation programs for facilities, utilities, manufacturing equipment, analytical instruments, manufacturing processes, cleaning processes, automation systems, computer systems, and information systems to comply with regulatory requirements of the Quality System
• Be the subject matter expert and technical leader for validation approaches, design and regulatory requirements
• Participate in the development and maintenance of applicable life cycle documentation, including but not limited to specifications (URS, FS, DS), risk assessments, validation plans, protocols (IQ, OQ, PQ), summary reports, requirement traceability matrices, and retirement plans.
• Ensure timely execution, review, and approval of Validation protocols/reports and SOPs
• Ensure the maintenance of validated systems to continue to meet intended use and cGMP
• Execute validation tasks in accordance with requirements of the validation plans and protocols
• Assist in the supervision of validation and engineering contract resources
• Support a risk-based approach to commissioning and qualification activities for facilities, utilities, manufacturing, analytical, and computerize/control systems
• Support a risk-based approach to the validation activities for clinical (Ph I - Ph III) to commercial manufacturing of drug substance
• Support regulatory changes through the provision of necessary validation documentation and change control activities
• Support the regulatory defense of validation protocols and summary reports during regulatory inspections and internal audits
• Support the continuous improvement initiatives for the validation of DSO manufacturing processes, equipment, facility, utility, and control systems
• Provide hands-on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements. Collect and analyze data to make data driven recommendations/decisions.
• Use engineering or scientific background to understand the technical aspects of validation to create strategies consistent with the operational and compliance needs
• Build and maintain successful cross-functional relationships with internal and external customers such as BD, DSO Quality/Manufacturing/QC/Facilities/ Engineering, CMC, Westport, and Regulatory

Qualifications

YOU BRING:

• B.S. in Biology, Chemistry, Biochemistry or a closely related discipline from an accredited institution (or equivalent years of industry experiences)
• Minimum of 10 years experience within validation, QA/QC, and or manufacturing is required.
• Experience in a GMP regulated environment required
• Experience using statistical, risk assessment, experimental design and process improvement tools is required
• Previous experience in Quality Assurance, Quality Control, Manufacturing or Engineering is desired, but not required
• Prior experiences in bioprocessing, automation, and IT are desired, but not required

ABBVIE LEADERSHIP SKILLS:

• Excellence Focused
• Boundaryless Mindset
• Open and Authentic
• Strategic Foresight

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.