Biogen
Quality Control EM/UM and Contamination Specialist
Biogen, Milwaukee, Wisconsin, United States, 53244
Quality Control EM/UM and Contamination Specialist
About This Role
We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state‑of‑the‑art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies.
What You’ll Do
Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices
Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA Guidance)
Partner with Manufacturing, Engineering, Quality Assurance, and Validation teams to assess and mitigate risks related to contamination control of product manufacturing
Author and review SOPs, protocols, and technical reports related to EM/UM and contamination control
Provide technical leadership in contamination control, risk assessments, and deviation investigations
Support regulatory inspections and audits as the subject matter expert (SME) for EM/UM and contamination control
Drive continuous improvement initiatives as it relates to contamination control
Oversee the EM/UM trending and training programs
Provide training and guidance on aseptic techniques and contamination control principles
Other duties as assigned
Who You Are
A strategic thinker with a deep understanding of microbiology and contamination control in a GMP‑regulated biologics environment
Detail‑oriented and analytical, with a strong commitment to data integrity and quality
Comfortable making decisions in a fast‑paced, dynamic environment
A clear communicator who can translate complex microbiological concepts to cross‑functional teams and regulatory bodies
Passionate about continuous improvement and innovation in contamination control
Resilient and adaptable, with a proactive approach to problem‑solving and risk mitigation
Required Skills
Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred)
Minimum 7–10 years of experience in pharmaceutical microbiology and sterility assurance within a GMP‑regulated biologics or pharmaceutical manufacturing environment
Minimum of 3 years of experience managing EM/UM and Contamination Control programs
Strong knowledge of aseptic processing, cleanroom classifications/operations, and environmental and utilities monitoring programs
Experience with regulatory inspections and audit readiness
Familiarity with regulatory requirements including FDA, EMA, and ICH guidelines
Proven leadership and team management skills
Excellent communication, problem‑solving, and organizational abilities
Preferred Skills
Experience with biologics drug substance manufacturing (e.g., cell culture, fermentation, purification)
Experience developing contamination control strategies
Proficiency in risk assessment tools (e.g., FMEA, HACCP)
Familiarity with statistical analysis and trending tools
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short‑ and Long‑Term Disability insurance
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.
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What You’ll Do
Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices
Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA Guidance)
Partner with Manufacturing, Engineering, Quality Assurance, and Validation teams to assess and mitigate risks related to contamination control of product manufacturing
Author and review SOPs, protocols, and technical reports related to EM/UM and contamination control
Provide technical leadership in contamination control, risk assessments, and deviation investigations
Support regulatory inspections and audits as the subject matter expert (SME) for EM/UM and contamination control
Drive continuous improvement initiatives as it relates to contamination control
Oversee the EM/UM trending and training programs
Provide training and guidance on aseptic techniques and contamination control principles
Other duties as assigned
Who You Are
A strategic thinker with a deep understanding of microbiology and contamination control in a GMP‑regulated biologics environment
Detail‑oriented and analytical, with a strong commitment to data integrity and quality
Comfortable making decisions in a fast‑paced, dynamic environment
A clear communicator who can translate complex microbiological concepts to cross‑functional teams and regulatory bodies
Passionate about continuous improvement and innovation in contamination control
Resilient and adaptable, with a proactive approach to problem‑solving and risk mitigation
Required Skills
Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred)
Minimum 7–10 years of experience in pharmaceutical microbiology and sterility assurance within a GMP‑regulated biologics or pharmaceutical manufacturing environment
Minimum of 3 years of experience managing EM/UM and Contamination Control programs
Strong knowledge of aseptic processing, cleanroom classifications/operations, and environmental and utilities monitoring programs
Experience with regulatory inspections and audit readiness
Familiarity with regulatory requirements including FDA, EMA, and ICH guidelines
Proven leadership and team management skills
Excellent communication, problem‑solving, and organizational abilities
Preferred Skills
Experience with biologics drug substance manufacturing (e.g., cell culture, fermentation, purification)
Experience developing contamination control strategies
Proficiency in risk assessment tools (e.g., FMEA, HACCP)
Familiarity with statistical analysis and trending tools
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short‑ and Long‑Term Disability insurance
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.
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