Validation Specialist I - BioSpace : Job Details

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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 including immunology, oncology, neuroscience, and eye care, as well as 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 TikTok.

Job Description

The primary responsibility of the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, the specialist will participate in implementing the Validation quality program and independently manage 5+ key projects simultaneously. The role may also involve coaching or supervising contractors and junior Validation Specialists.

• Provide Quality Assurance oversight of site validation documents, practices, and reports to the site Quality organization.
• Participate in the implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensure all practices and procedures comply with company policies and regulations for the Quality areas.
• Execute tasks to implement the Validation Master Plan and maintain validation of equipment, utilities, facilities, automated systems, information systems, cleaning, manufacturing processes, laboratory instruments, and analytical methods to ensure product consistency.
• Investigate validation failures thoroughly, document findings accurately, and include them in the plant CAPA system as required.
• Collaborate with plant and external engineering teams on new installations/systems to ensure documentation complies with cGMP and supports validation.
• Supervise contract validation resources as needed.
• Lead, author, or review investigations and implement preventive and corrective actions.

Qualifications

• Bachelor's Degree in Biology, Chemistry, Engineering, or related field.
• 6+ years of experience in Manufacturing, Quality, or Engineering, including 4 major validation subjects.
• Strong communication, problem-solving, and analytical skills.
• Interpersonal skills including negotiation and influence without authority.
• Supervisory experience preferred.
• Ability to manage multiple complex projects simultaneously.
• Knowledge of quality and compliance regulations affecting pharmaceutical manufacturing is preferred.

Additional Information

• Salary range: $82,500 - $157,500, dependent on location and experience.
• Comprehensive benefits including paid time off, insurance, 401(k), and participation in incentive programs.
• Equal opportunity employer committed to diversity and inclusion.

Note: Compensation details are subject to change and are at the company's discretion.

Location: North Chicago, IL.

Seniority level: Entry level.

Employment type: Full-time.

Job function: Quality Assurance.

Industries: Pharmaceutical, Biotechnology.