Microbiology Department Project Lead
AbbVie
September 04, 2026
Remote friendly (Waco, TX)
United States
$96,500 - $183,500 USD yearly
Operations
The Microbiology Department Project Lead serves as the technical leader for a sterile pharmaceutical manufacturing site, overseeing microbiological testing, environmental monitoring, contamination control, laboratory operations, projects, change controls, GMP documentation, method qualification and validation, investigations, deviations, and CAPAs. Coordinates with cross-functional partners, assesses microbiological risks, drives continuous improvement, monitors regulatory and scientific developments, supports inspections and audits, analyzes data and trends, manages project resources, and mentors personnel.
Key Responsibilities:
- Serve as technical lead for Microbiology; provide scientific oversight for microbiological testing, environmental monitoring, contamination control, and lab operations.
- Lead and manage microbiology-related projects (initiation through implementation).
- Own/coordinate microbiology change controls; assess impact; ensure timely closure of quality records.
- Author/review/approve/implement microbiology procedures, specifications, protocols, and technical documents to maintain GMP compliance.
- Lead method qualification, verification, validation, and transfer for microbiological/rapid methods.
- Provide technical review/approval of investigations, deviations, lab events, and CAPAs related to microbiological processes.
- Partner with Quality Assurance, Manufacturing, Engineering, Validation, and Regulatory Affairs.
- Assess microbiological risks from process changes, equipment/facility upgrades, and contamination control strategies.
- Drive continuous improvement for laboratory efficiency, data integrity, compliance, and contamination control.
- Support inspections/audits as microbiology subject matter expert; present technical justifications and data.
- Analyze trends to identify risks and recommend actions to strengthen product quality/patient safety.
- Coordinate cross-functional teams for project timelines, deliverables, and resource planning.
Preferred Leadership Responsibilities:
- Act as primary microbiology SME; mentor staff; champion scientific excellence, compliance, and continuous improvement.
Qualifications:
- Bachelor’s degree in Science/Engineering/Business Management (or equivalent technical experience).
- 5+ years relevant Quality experience in GMP pharma/biologics and/or medical device manufacturing.
- Strong understanding of cGxPs, regulatory inspections, and global regulations/standards.
- Project Management experience; lead cross-functional teams in global/matrixed settings.
- Strong communication, interpersonal, time management, influence, and problem-solving skills.
- Proficient in Office 365.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for short-term incentive programs.
Key Responsibilities:
- Serve as technical lead for Microbiology; provide scientific oversight for microbiological testing, environmental monitoring, contamination control, and lab operations.
- Lead and manage microbiology-related projects (initiation through implementation).
- Own/coordinate microbiology change controls; assess impact; ensure timely closure of quality records.
- Author/review/approve/implement microbiology procedures, specifications, protocols, and technical documents to maintain GMP compliance.
- Lead method qualification, verification, validation, and transfer for microbiological/rapid methods.
- Provide technical review/approval of investigations, deviations, lab events, and CAPAs related to microbiological processes.
- Partner with Quality Assurance, Manufacturing, Engineering, Validation, and Regulatory Affairs.
- Assess microbiological risks from process changes, equipment/facility upgrades, and contamination control strategies.
- Drive continuous improvement for laboratory efficiency, data integrity, compliance, and contamination control.
- Support inspections/audits as microbiology subject matter expert; present technical justifications and data.
- Analyze trends to identify risks and recommend actions to strengthen product quality/patient safety.
- Coordinate cross-functional teams for project timelines, deliverables, and resource planning.
Preferred Leadership Responsibilities:
- Act as primary microbiology SME; mentor staff; champion scientific excellence, compliance, and continuous improvement.
Qualifications:
- Bachelor’s degree in Science/Engineering/Business Management (or equivalent technical experience).
- 5+ years relevant Quality experience in GMP pharma/biologics and/or medical device manufacturing.
- Strong understanding of cGxPs, regulatory inspections, and global regulations/standards.
- Project Management experience; lead cross-functional teams in global/matrixed settings.
- Strong communication, interpersonal, time management, influence, and problem-solving skills.
- Proficient in Office 365.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for short-term incentive programs.