Senior Microbiology Program Lead – GMP & Compliance

ABBVIE; Waco (TX); On-site; USD 97,000 - 184,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Medical/dental/vision insurance

Job summary

AbbVie is seeking a Microbiology Department Project Lead to act as the technical leader for a sterile pharmaceutical manufacturing site. You will oversee microbiological testing, environmental monitoring, contamination control, laboratory operations, and GMP documentation, while coordinating with cross-functional partners.

You will drive method qualification, investigations, deviations, CAPAs, and continuous improvement, mentor personnel, and ensure regulatory readiness for inspections and

Qualifications

• Bachelor's degree in a relevant field and technical experience in GMP environments.
• Strong knowledge of cGxPs and regulatory inspections.
• Experience leading cross-functional project teams in global or matrixed setups.
• Excellent written and spoken communication and problem-solving skills.
• Proficiency with standard Office applications.

Responsibilities

• Lead microbiology projects and provide scientific oversight for testing and environmental monitoring.
• Manage change controls, investigations, deviations, CAPAs, and quality records.
• Author, review, and approve microbiology procedures and validation activities.
• Coordinate with QA, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Mentor staff and drive continuous improvement in laboratory operations.

Skills

Communication

Interpersonal skills

Project Management

Cross-functional leadership

Regulatory knowledge

Education

Bachelor's degree in Science/Engineering/Business Management or equivalent technical work experience

Tools

Office 365

Job description

AbbVie is seeking a Microbiology Department Project Lead to act as the technical leader for a sterile pharmaceutical manufacturing site. You will oversee microbiological testing, environmental monitoring, contamination control, laboratory operations, and GMP documentation, while coordinating with cross-functional partners.

You will drive method qualification, investigations, deviations, CAPAs, and continuous improvement, mentor personnel, and ensure regulatory readiness for inspections and