This role ensures that environmental monitoring, microbiological testing, and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing ...
This role ensures that environmental monitoring, microbiological testing, and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing ...
Manager, QC Microbiology (Sterile Drug Manufacturing & Fill Finish)
Danbury, CT · On-site
$116K - $174K/yr
This role ensures that environmental monitoring, microbiological testing, and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing ...
Manager, QC Microbiology (Sterile Drug Manufacturing & Fill Finish)
Danbury, CT · On-site
$116K - $174K/yr
This role ensures that environmental monitoring, microbiological testing, and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing ...
Experience with FMEA, control plans, 4C, DMAIC, 8D, or other structured problem-solving frameworks. * Background in surface science, contamination physics, or thinfilm materials. * Experience ...
Experience with FMEA, control plans, 4C, DMAIC, 8D, or other structured problem-solving frameworks. * Background in surface science, contamination physics, or thinfilm materials. * Experience ...
Experience with FMEA, control plans, 4C, DMAIC, 8D, or other structured problem-solving frameworks. * Background in surface science, contamination physics, or thin-film materials. * Experience ...
Experience with FMEA, control plans, 4C, DMAIC, 8D, or other structured problem-solving frameworks. * Background in surface science, contamination physics, or thin-film materials. * Experience ...
Establish a harmonized approach to sterilization, contamination control, and sterility assurance across the enterprise * Serve as the final Quality authority for sterility related decisions ...
Establish a harmonized approach to sterilization, contamination control, and sterility assurance across the enterprise * Serve as the final Quality authority for sterility related decisions ...
MFG Support-Label Area
Shelton, CT · On-site
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
MFG Support-Label Area
Shelton, CT · On-site
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
MFG Support-Label Area
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
MFG Support-Label Area
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
MFG Support-Label Area
Shelton, CT · On-site
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
Quick apply
MFG Support-Label Area
Shelton, CT · On-site
$17.75 - $24/hr
SOP-013 Cleaning, Sanitation and Contamination Control * SOP-014 Personal Health and Cleanliness Computer Training Manage 2000 * wo.close * wo.status * activity * items.lot * auto.wo.close * change ...
Director, High Purity Semiconductor Operations - CONFIDENTIAL
Farmington, CT · On-site
$180K - $230K/yr
Maintain ultra-high purity manufacturing standards, including strict contamination control and cleanroom discipline * Partner with Engineering to industrialize new products and custom engineered ...
Director, High Purity Semiconductor Operations - CONFIDENTIAL
Farmington, CT · On-site
$180K - $230K/yr
Maintain ultra-high purity manufacturing standards, including strict contamination control and cleanroom discipline * Partner with Engineering to industrialize new products and custom engineered ...
Precision Assembly Technician
Middlefield, CT · On-site
$17 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Precision Assembly Technician
Middlefield, CT · On-site
$17 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Precision Assembly Technician (1st shift)
Middlefield, CT · On-site
$17 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Precision Assembly Technician (1st shift)
Middlefield, CT · On-site
$17 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate with engineering to support process development, validation, and continuous improvement.
Electrical Assembler (1st shift)
$16.75 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate effectively with peers, engineering and supervision to support the build progress, problem ...
Electrical Assembler (1st shift)
$16.75 - $21.25/hr
Maintain cleanroom protocols and ensure contamination control during all assembly processes. * Collaborate effectively with peers, engineering and supervision to support the build progress, problem ...
Cleanroom manufacturing setting requiring adherence to strict contamination control protocols * Frequent interaction with production operators, engineers, and quality leadership * Hands-on role with ...
Cleanroom manufacturing setting requiring adherence to strict contamination control protocols * Frequent interaction with production operators, engineers, and quality leadership * Hands-on role with ...
Cleanroom manufacturing setting requiring adherence to strict contamination control protocols * Frequent interaction with production operators, engineers, and quality leadership * Hands-on role with ...
Cleanroom manufacturing setting requiring adherence to strict contamination control protocols * Frequent interaction with production operators, engineers, and quality leadership * Hands-on role with ...
Manager, QA Validation (Sterile Manufacturing)
$116K - $174K/yr
... contamination control, fill-finish and packaging operations. Working knowledge of validation lifecycle principles, risk management, and data integrity requirements. Familiarity with regulatory ...
Manager, QA Validation (Sterile Manufacturing)
$116K - $174K/yr
... contamination control, fill-finish and packaging operations. Working knowledge of validation lifecycle principles, risk management, and data integrity requirements. Familiarity with regulatory ...
Manager, QA Validation (Sterile Manufacturing)
Danbury, CT · On-site
$116K - $174K/yr
... contamination control, fill-finish and packaging operations. Working knowledge of validation lifecycle principles, risk management, and data integrity requirements. Familiarity with regulatory ...
Manager, QA Validation (Sterile Manufacturing)
Danbury, CT · On-site
$116K - $174K/yr
... contamination control, fill-finish and packaging operations. Working knowledge of validation lifecycle principles, risk management, and data integrity requirements. Familiarity with regulatory ...
Director of Manufacturing, High Purity
$158K - $237K/yr
Maintain rigorous contamination control and cleanliness standards. Oversee production of high purity filters, gas diffusers, flow restrictors, and IGScompatible components. Partner with Engineering ...
Director of Manufacturing, High Purity
$158K - $237K/yr
Maintain rigorous contamination control and cleanliness standards. Oversee production of high purity filters, gas diffusers, flow restrictors, and IGScompatible components. Partner with Engineering ...
Strong understanding of fluid system principles including pressure loss, flow control, thermal effects, contamination control, and system interfaces. * Experience leading technical reviews and making ...
Strong understanding of fluid system principles including pressure loss, flow control, thermal effects, contamination control, and system interfaces. * Experience leading technical reviews and making ...
Strong understanding of fluid system principles including pressure loss, flow control, thermal effects, contamination control, and system interfaces. * Experience leading technical reviews and making ...
Strong understanding of fluid system principles including pressure loss, flow control, thermal effects, contamination control, and system interfaces. * Experience leading technical reviews and making ...
Contamination Control information
What are the key skills and qualifications needed to thrive in Contamination Control, and why are they important?
What are common challenges faced in a Contamination Control role, and how can they be addressed?
What is contamination control?
What is the difference between Contamination Control vs Cleanroom Technician?
| Aspect | Contamination Control | Cleanroom Technician |
|---|---|---|
| Certifications | ISO certifications, contamination control training | Cleanroom operation training, ISO standards |
| Work Environment | Manufacturing, pharmaceutical, biotech cleanrooms | Cleanroom facilities in pharma, electronics, biotech |
| Employer & Industry Usage | Quality assurance, contamination prevention teams | Operational staff maintaining cleanroom standards |
Contamination Control focuses on preventing and managing contamination risks across various environments, often involving protocols, inspections, and training. Cleanroom Technicians operate within cleanrooms, executing specific procedures to maintain cleanliness standards. While both roles require similar certifications and work in related environments, Contamination Control has a broader scope, emphasizing contamination prevention strategies, whereas Cleanroom Technicians focus on daily operational tasks within cleanrooms.

$116K - $174K/yr
Full-time
Posted 4 days ago
Job description
- Supervise and mentor microbiologists and laboratory analysts, ensuring high technical competency and adherence to cGMP.
- Oversee scheduling, workload prioritization, and resource planning to support manufacturing and fill–finish operations.
- Ensure laboratory operations comply with FDA, EMA, ICH, and Annex 1 requirements.
- Maintain a culture of data integrity, continuous improvement, and operational excellence.
- Serve as a technical lead for Aseptic Process Simulations (Media Fills). This includes designing "worst-case" simulation protocols, managing the incubation and inspection of units, and investigating any failures to identify root causes.
- Provide microbiology expertise for aseptic processing, sterile filtration, filling operations, lyophilization, and visual inspection.
- Lead oversight of environmental monitoring (EM) programs for cleanrooms, isolators, RABS, and filling suites.
- Review and approve EM trend reports, sterility test results, bioburden data, endotoxin results, and water system monitoring.
- Partner with Manufacturing, QA, and Engineering to ensure contamination control strategies are robust and effective.
- Lead or support investigations for microbiology‑related deviations, EM excursions, sterility failures, and contamination events.
- Develop and implement CAPAs to prevent recurrence and strengthen contamination control.
- Review and approve SOPs, test methods, validation protocols, and laboratory documentation.
- Support regulatory inspections and internal audits, serving as the subject matter expert for microbiology and aseptic controls.
- Ensure qualification and ongoing monitoring of clean utilities (WFI, clean steam, compressed gases).
- Oversee qualification, calibration, and maintenance of microbiology laboratory equipment (e.g., isolators, incubators, endotoxin systems).
- Ensure validated and compliant microbiological test methods, including sterility testing, endotoxin, bioburden, microbial ID, and growth promotion.
- Manage sample flow, chain of custody, and timely release of microbiological data to support production schedules.
- Drive continuous improvement initiatives to enhance testing efficiency, contamination control, and laboratory workflow.
- Bachelor’s or master’s degree in microbiology, Biology, or related Life Science discipline.
- 10+ years of QC Microbiology experience with at least 2 years in a supervisory or management capacity in a GMP sterile drug manufacturing environment.
- Direct experience with media fill validation, smoke studies, and environmental monitoring in Grade A/B (Class 100) environments.
- Strong knowledge of aseptic processing, contamination control, and fill–finish operations.
- Experience with environmental monitoring programs, sterility testing, Bacterial Endotoxin Testing, and cleanroom classification.
- In-depth understanding of the 2022 revised EU Annex 1, FDA 21 CFR 211, USP lt;71 gt;, lt;85 gt;, and lt;1116 gt;, and ICH Q7–Q10.
- Demonstrated leadership experience, including coaching, training, and performance management.
- Excellent communication, documentation, and cross‑functional collaboration skills.
- Experience with isolator‑based sterility testing and aseptic filling technologies.
- Knowledge of rapid microbiological methods (RMM) and modern contamination control strategies.
- Experience supporting regulatory inspections (FDA, EMA, MHRA).
- Understanding of water system microbiology and clean utility qualification.
- Lean/Six Sigma or continuous improvement training.
About MannKind
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Danbury, CT, US
Year founded
1991