Job Title: Senior Manager, Sterility Assurance/Micro (7am - 3pm)
Requisition ID: JR - 183156
Location: Marion, North Carolina, United States
Facility Address: 65 Pitts Station Rd, Marion, NC 28752
Company Overview – Baxter
At Baxter, we are committed to saving and sustaining lives through high-quality products used worldwide. Our mission connects every team member to the positive impact we create for millions of patients globally. For over 85 years, Baxter has pioneered medical innovations transforming healthcare.
Position Summary
As Senior Manager of Sterility Assurance/Microbiology, you will lead and drive initiatives to ensure contamination control policies and practices meet regulatory and company standards. You will oversee the Sterility Assurance program and foster continuous improvement across clean-room environments, manufacturing processes, and products.
Key Responsibilities
Develop, implement, and lead continuous improvement initiatives within the Sterility Assurance program.
Ensure compliance with sterility assurance regulations and serve as Subject Matter Expert (SME) during regulatory, internal, and external audits.
Provide microbiological expertise in SOPs, change control, and validations.
Assist in developing and managing site contamination control strategies.
Prioritize and improve cleaning procedures across multiple operating lines.
Oversee sterilization and contamination control efforts in Operations to meet regulatory standards.
Write, review, and approve environmental cleaning protocols.
Design and implement cleanroom behavior and contamination control training programs.
Conduct microbiological and sterility risk assessments.
Support facility projects through environmental Failure Modes and Effects Analysis (FMEAs), risk assessments, and change impact evaluation.
Coordinate responses to environmental/process conditions detected during Real Time Risk Assessments (RTRA).
Lead root cause investigations of microbiological and manufacturing nonconformances; collaborate on CAPA resolution.
Establish response plans for environmental events in cleanrooms.
Write and revise SOPs related to continuous improvement, CAPAs, and periodic reviews.
Conduct GEMBA-style assessments of manufacturing operations identifying deficiencies and improvement opportunities.
Partner with regional sterility assurance authorities to align policies and achieve company objectives.
Qualifications
Bachelor’s degree in Microbiology, Biology, or related science.
Minimum 7 years of experience in a cGMP-regulated industry.
At least 5 years of leadership/supervision experience in aseptic or sterile manufacturing.
Strong knowledge of aseptic and terminal sterilization processes.
Expertise in contamination control practices and engineering controls (cleanroom operations, process air, water for injection, etc.).
Proficient in standard microbiological testing (environmental monitoring, bioburden, bacterial endotoxin).
Familiar with FDA cGMP, EU Annex-I, and ISO 14644-1 standards.
Expert in aseptic technique, cleanroom behavior, cleaning methodologies, and risk assessments.
Strong communication, project management, analytical, troubleshooting, and investigative skills.
Proficient in problem-solving methodologies (DMAIC, Ishikawa diagram).
Excellent technical writing skills.
Experience interacting confidentially with FDA or similar regulatory agencies.
Compensation
Estimated base salary range: $136,000 - $187,000 annually
Salary may vary based on location, skills, experience, and other factors.
Position may be eligible for discretionary bonuses and long-term incentives.
Additional Information
Other duties may be assigned; role requires flexibility and occasional overtime.
Applicants must be authorized to work in the U.S.; sponsorship is not available.
Job code: #LI-EB1
Benefits (U.S., Except Puerto Rico)
Medical, dental, and vision coverage starting on Day 1.
160 hours Paid Time Off plus paid holidays.
401(k) Retirement Savings Plan with company match.
Employee Stock Purchase Program (ESPP).
Paid parental leave.
Tuition reimbursement.
Flexible Spending Accounts (FSA).
Family and medical leaves of absence.
Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), childcare benefits.
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Equal Employment Opportunity
Baxter is an Equal Opportunity Employer and considers qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, disability, or other protected characteristics.
🔗 Workplace Discrimination Rights
Reasonable Accommodations
Baxter provides reasonable accommodations for individuals with disabilities during the application and interview process.
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Recruitment Fraud Notice
Beware of scams impersonating Baxter employees or recruiters. Baxter does not request personal or financial information via unofficial channels.
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