Job Title: Head of Microbiology
Job Description
The Head of Microbiology leads all microbiological operations within a sterile injectable pharmaceutical manufacturing environment. This role oversees microbiology laboratory activities, environmental monitoring programs, sterility assurance initiatives, and aseptic process support while ensuring full compliance with FDA, cGMP, USP, and other applicable regulatory requirements. The position provides strategic leadership, technical expertise, and operational oversight to uphold the highest standards of product quality, patient safety, and regulatory compliance.
Responsibilities
- Lead, develop, and mentor a team of microbiologists and laboratory personnel, fostering a collaborative and high-performance culture.
- Establish clear departmental goals, priorities, and performance expectations aligned with overall business and quality objectives.
- Ensure all personnel are fully trained, qualified, and authorized before performing assigned laboratory activities.
- Drive a culture of quality, compliance, safety, and continuous improvement across microbiology operations.
- Oversee microbiological testing programs, including sterility testing, bioburden testing, bacterial endotoxin testing (BET), and microbial limits testing (MLT).
- Manage sample collection, testing, data review, interpretation, and reporting to ensure accurate, timely, and compliant results.
- Support manufacturing operations through environmental monitoring of classified cleanroom environments and utility systems.
- Perform and oversee microbiological testing of raw materials, packaging components, water systems, and other utilities.
- Develop, author, review, and approve microbiology-related procedures, test methods, and Standard Operating Procedures (SOPs).
- Lead method validations, method transfers, and method suitability studies to ensure robust and reliable microbiological methods.
- Prepare, review, and approve protocols and reports for microbiology equipment and laboratory instrument qualifications and validations.
- Ensure all laboratory methods remain compliant with current regulatory and industry standards and best practices.
- Provide microbiological support for aseptic manufacturing operations, including routine and complex process activities.
- Lead and support media fill (aseptic process simulation) studies, including protocol development, execution oversight, and results evaluation.
- Partner closely with Manufacturing, Quality Assurance, and Validation teams to maintain and enhance contamination control strategies.
- Monitor and trend environmental monitoring data to identify risks, deviations, and opportunities for corrective and preventive actions.
- Ensure ongoing compliance with FDA, cGMP, USP, and other applicable regulatory requirements in all microbiology activities.
- Lead and support microbiology-related investigations, including deviations, out-of-specification (OOS) results, non-conformances, and environmental excursions.
- Manage and support Quality Systems activities, including change controls, deviations, corrective and preventive actions (CAPA), quality risk management (QRM), product complaints, and product recalls.
- Maintain complete and accurate laboratory documentation and ensure data integrity standards are consistently met.
- Develop and maintain quality metrics, dashboards, and microbiological trend reports to support data-driven decision-making.
- Analyze laboratory and environmental monitoring data to identify trends, risks, and opportunities for process and system improvement.
- Recommend and implement initiatives that enhance laboratory efficiency, regulatory compliance, and overall operational performance.
- Contribute to preparation for and participation in regulatory and customer inspections related to microbiology and sterility assurance.
Essential Skills
- Extensive experience in pharmaceutical microbiology within a sterile manufacturing environment.
- Strong knowledge of FDA regulations, cGMP requirements, USP microbiological standards, and aseptic processing principles.
- Demonstrated experience leading microbiology laboratories, environmental monitoring programs, and sterility assurance activities.
- Hands-on expertise with sterility testing, bioburden testing, bacterial endotoxin testing (BET), and microbial limits testing (MLT).
- Experience with method validation, method transfers, method suitability studies, and laboratory investigations.
- Proven ability to manage and support Quality Systems activities, including change controls, deviations, CAPA, QRM, product complaints, and product recalls.
- Strong leadership skills with the ability to build, mentor, and develop high-performing technical teams.
- Excellent communication skills, both written and verbal, for effective interaction with cross-functional stakeholders and regulatory bodies.
- Strong problem-solving and analytical skills, with the ability to interpret complex microbiological and environmental data.
- Effective project management skills to plan, prioritize, and execute multiple initiatives in a regulated environment.
- In-depth understanding of contamination control strategies and sterility assurance concepts in sterile injectable manufacturing.
- Technical proficiency in microbiology, including microbology (microbiology), bioburden, and endotoxin-related testing.
Additional Skills & Qualifications
- Bachelor"s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.
- Advanced degree in a relevant scientific field is preferred.
- Experience supporting sterile injectable manufacturing operations.
- Previous participation in FDA, customer, or other regulatory inspections.
- Knowledge of contamination control strategies and Annex 1 requirements.
- Proven ability to build and lead high-performing microbiology teams.
- Familiarity with environmental monitoring programs in classified cleanroom environments.
- Experience working with water systems, utility systems, and testing of raw materials and packaging components.
- Experience in developing and approving Standard Operating Procedures (SOPs) and technical protocols.
- Experience creating and maintaining quality metrics, dashboards, and trend reports for microbiological data.
Work Environment
This role operates within a sterile injectable pharmaceutical manufacturing environment that includes classified cleanrooms and microbiology laboratories. The position supports manufacturing operations and environmental monitoring in controlled areas and works closely with cross-functional teams in Quality, Manufacturing, and Validation. The typical work schedule is first shift, Monday through Friday, from 8:00 a.m. to 5:00 p.m. The environment emphasizes strict adherence to cGMP, FDA, and USP requirements, robust contamination control practices, and consistent application of aseptic processing principles. Appropriate cleanroom attire and laboratory safety practices are required when working in controlled or laboratory areas.
Job Type & Location
This is a Contract position based out of Boca Raton, FL.
Pay and Benefits
The pay range for this position is $42.00 - $45.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Boca Raton,FL.
Application Deadline
This position is anticipated to close on Aug 11, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
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