Microbiology Department Project Lead

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.  The role also 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 while championing scientific excellence compliance and operational effectiveness. 

For a Microbiology Department Project Lead role supporting a sterile pharmaceutical manufacturing site you can position the role as the technical leader responsible for microbiology program governance laboratory projects and quality system improvements.

Key Responsibilities

• Serve as the technical lead for the Microbiology department providing scientific oversight and guidance for microbiological testing environmental monitoring contamination control and laboratory operations.
• Lead and manage microbiology-related projects from initiation through implementation ensuring alignment with business objectives regulatory requirements and site priorities.
• Own and coordinate microbiology change controls assessing technical impact defining implementation strategies and ensuring timely closure of quality records.
• Author review approve and implement microbiology procedures specifications protocols and technical documents to maintain compliance with current GMP requirements.
• Lead method qualification verification validation and transfer activities for microbiological and rapid microbiological methods.
• Provide technical review and approval of investigations deviations laboratory events and CAPAs related to microbiological processes and testing.
• Partner with Quality Assurance Manufacturing Engineering Validation and Regulatory Affairs to support product and process changes new product introductions and operational improvements.
• Assess microbiological risks associated with process changes equipment modifications facility upgrades and contamination control strategies.
• Drive continuous improvement initiatives to enhance laboratory efficiency data integrity compliance and contamination control effectiveness.
• Monitor and interpret emerging regulatory expectations industry standards and scientific advancements to ensure microbiology programs remain compliant and inspection-ready.
• Support regulatory inspections and customer audits by serving as the microbiology subject matter expert and presenting technical justifications data and program strategies.
• Analyze microbiological data and trends to identify risks improve process understanding and recommend actions that strengthen product quality and patient safety.
• Coordinate cross-functional teams to ensure successful execution of microbiology projects timelines deliverables and resource planning.

Preferred Leadership Responsibilities

• Act as the primary microbiology SME for technical decision-making and strategic laboratory initiatives.
• Mentor microbiologists and laboratory personnel on scientific principles regulatory expectations and best practices.
• Champion a culture of scientific excellence compliance continuous improvement and operational effectiveness within the Microbiology organization.

Qualifications :

• Bachelors degree in Science/Engineering/Business Management or equivalent technical work experience
• 5 years of relevant Quality experience in a GMP pharmaceutical biologics and/or medical device manufacturing environment
• Strong understanding of cGxPs regulatory inspections regulatory documents global regulations and standards
• Experience in Project Management and leading cross-functional project teams with technical professionals in a global and/or complex matrixed organization
• Strong oral and written communication interpersonal time management influence and problem-solving skills
• Proficient in the use of standard software applications including Office 365

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  including  geographic location and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to  participate in our short-term incentive programs.  

Note: No amount of pay is  considered to be wages or compensation until such amount is earned  vested  and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Companys sole and absolute discretion unless and until paid and may be  modified at the Companys sole and absolute discretion  consistent with applicable law. 

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