Quality Assurance Engineering Lead

We are now hiring a Quality Assurance Engineering Lead to join AbbVies Global Engineering function. This role offers an exciting opportunity to serve as a key quality partner on global engineering programs helping ensure that GMP contamination control and quality requirements are built into facility utility and equipment design from concept through execution.

The ideal candidate will collaborate with cross-functional teams across AbbVie sites and global functions to support innovative compliant and high-quality solutions that advance our mission.

Purpose

The Quality Assurance Engineering Lead is responsible for providing quality assurance oversight for global engineering programs which may include projects related to biologics (drug substance/drug product) API aseptic manufacturing terminally sterilized products medical devices and laboratory environments. This role ensures that quality and GMP requirements are incorporated throughout the project lifecycle.

As a member of the global engineering project team this individual serves as the primary quality representative for key global engineering programs and collaborates with AbbVie site and engineering cross-functional teams to ensure GMP principles and contamination control requirements are upheld.

Responsibilities

• Provide quality assurance governance and oversight for global engineering programs including projects related to biologics (drug substance/drug product) API aseptic manufacturing terminally sterilized products medical devices and laboratories.
• Provide quality assurance guidance during facility utility and equipment design reviews as well as GMP reviews from concept design through detailed design. Ensure identified risks are mitigated during the design phase.
• Lead contamination control risk assessments with cross-functional teams from AbbVie sites and global functional groups to ensure GMP regulatory compliance and to identify evaluate and mitigate contamination risks by design.
• Lead the development of the initial contamination control strategy for global engineering programs at AbbVie sites.
• Make key decisions regarding GMP and quality requirements for facility utility and equipment design ensuring potential regulatory compliance risks and contamination risks are addressed during design.
• Partner with the project lead to provide updates on regulatory compliance risks and quality risks for inclusion in the project risk register.
• Participate in system risk assessments (SRAs) and review qualification documents as required in accordance with risk-based qualification requirements throughout the project lifecycle.
• Determine critical design elements impacting product quality and assess proposed test plans to qualify facilities utilities and equipment.
• Build strong relationships and collaborate with AbbVie site quality teams and cross-functional stakeholders to achieve quality deliverables including GMP and quality risk mitigation for global engineering programs.
• Apply knowledge of aseptic manufacturing terminal sterilization API and biologics (drug substance/drug product) including related facility equipment and utility GMP requirements.
• Maintain knowledge of applicable regulations and expectations from FDA EMA and regional health authorities.
• Apply quality risk management principles and contamination control strategy expertise to support compliant and effective project execution.

Qualifications :

• Bachelors or Masters degree in Engineering or a science-related discipline with relevant experience in some or all of the following areas: API biomanufacturing aseptic manufacturing terminal sterilization medical devices and QC/microbiology laboratories.
• 8 years of experience in the pharmaceutical industry in Quality Assurance Engineering Operations or Technical Support.
• Demonstrated ability to operate in a fast-paced environment requiring urgency flexibility and the ability to manage multiple priorities while ensuring quality and GMP deliverables remain on schedule.
• Strong quality assurance mindset with experience in Quality Assurance Engineering Operations or a technical discipline and a comprehensive understanding of biological and/or pharmaceutical technologies.
• Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements.
• Knowledge and experience with risk-based qualification including ISPE Baseline Guide Volume 5: Commissioning and Qualification and quality risk management principles such as ICH Q9.
• Self-directed and self-motivated with the ability to represent the quality function in a high-paced project environment.
• Ability to work closely with key project stakeholders to maintain delivery schedules and minimize potential delays.
• Excellent verbal and written communication skills.

Additional Information :

Join AbbVie as a Quality Assurance Engineering Lead and help shape quality and compliance across critical global programs. If youre passionate about driving GMP excellence contamination control and quality by design in a dynamic cross-functional environment we encourage you to apply and make an impact.

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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Work :

No

Employment Type :

Full-time