Manager, Aseptic Process Excellence

Job SummarySalary Range: $100,000 to $140,000
This position is eligible to participate in a bonus plan with a target of 6% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Leads the site-wide aseptic training and personnel qualification program, providing strategic direction for aseptic technique, contamination control, and operator performance within regulated manufacturing environments. Accountable for the effectiveness of training systems, intervention reduction initiatives, personnel qualification standards, and remediation strategies designed to minimize human error and mitigate contamination risk. Directs the assessment, prioritization, and resolution of training gaps, aseptic excursions, and performance trends through data-driven analysis and targeted development programs. Ensures all gown-qualified personnel maintain the knowledge, skills, and competencies required to perform within aseptic environments in accordance with regulatory requirements, corporate standards, and industry best practices. Partners with Production, Quality, Validation, Engineering, and Site Leadership to drive a culture of aseptic excellence, operational discipline, and compliance. Champions continuous improvement by identifying opportunities to enhance training effectiveness, strengthen contamination control practices, optimize qualification processes, and implement sustainable solutions that improve operational performance, inspection readiness, and overall manufacturing quality. Influences cross-functional stakeholders to advance organizational capability, improve business outcomes, and support a culture of continuous learning and operational excellence across aseptic manufacturing operations.

Job Responsibilities:

• Provide strategic leadership and oversight for the Aseptic Training and Mentorship Program, ensuring the continued development, effectiveness, and compliance of aseptic operations across the site.

• Direct the planning, allocation, and management of Aseptic Mentor resources, staffing models, and schedules to ensure continuous operational support, training coverage, and alignment with business objectives.

• Lead the development, coaching, performance management, and succession planning of Aseptic Training personnel, fostering a high-performing team capable of supporting current and future organizational needs.

• Establish departmental goals, key performance indicators (KPIs), and strategic priorities that support operational excellence, employee capability development, regulatory compliance, and continuous improvement initiatives.

• Serve as the site subject matter expert for aseptic behavior, personnel qualification programs, and contamination control practices, providing leadership guidance to Production, Quality, Validation, Engineering, and Maintenance organizations.

• Partner with site leadership to assess training effectiveness, workforce competency, and aseptic performance trends, implementing strategies to strengthen technical capabilities and mitigate operational risk.

• Provide regular updates and strategic recommendations to Production and Quality Management regarding aseptic compliance, personnel performance, contamination control initiatives, and emerging operational challenges.

• Direct and oversee the design, implementation, maintenance, and continuous improvement of aseptic training curricula, qualification programs, and competency assessment processes.

• Ensure the effective onboarding, qualification, and ongoing development of Aseptic Filling Operators and other gown-qualified personnel through a comprehensive training strategy incorporating classroom instruction, practical application, and performance evaluation.

• Govern the Advanced Aseptic Training Program for all gown-qualified personnel, ensuring program effectiveness, compliance with regulatory expectations, and alignment with site contamination control strategies.

• Lead site efforts to standardize aseptic techniques, cleanroom behaviors, and contamination control practices across manufacturing operations, driving consistency and compliance throughout the organization.

• Oversee process simulation (media fill) training programs and qualification activities, including participation tracking, performance trending, and the evaluation of aseptic behaviors associated with simulation outcomes.

• Partner with Production, Quality Control Microbiology, Validation, and Maintenance leadership to establish and maintain performance expectations related to aseptic behavior and cleanroom practices.

• Lead investigations and training-related corrective and preventive actions (CAPAs) associated with environmental monitoring excursions, aseptic interventions, and personnel-related contamination events.

• Provide leadership and oversight for airflow visualization studies, aseptic process evaluations, and contamination control assessments to ensure continued process understanding and regulatory readiness.

• Analyze key performance indicators, qualification trends, environmental monitoring data, and training metrics to identify opportunities for performance improvement and mitigate compliance risks.

• Present departmental performance metrics, training effectiveness measures, compliance trends, and strategic initiatives to plant, regional, and corporate leadership teams.

• Collaborate with cross-functional stakeholders and corporate partners to develop, implement, and continuously improve aseptic training programs, qualification standards, and best practices across all Fresenius Kabi USA sites.

• Drive the standardization and harmonization of aseptic practices, training methodologies, and cleanroom management systems throughout the organization to support regulatory compliance and operational excellence.

• Provide leadership support during regulatory inspections and customer audits, serving as the primary representative for aseptic training programs, qualification processes, personnel interventions, and training laboratory operations.

• Ensure the Aseptic Training Laboratory is maintained in a state of regulatory compliance and operational readiness, including oversight of facility housekeeping, equipment maintenance, and training infrastructure.

• Champion a culture of continuous improvement, accountability, and operational excellence through the identification, prioritization, and execution of process enhancement initiatives.

• Develop, manage, and monitor departmental operational budgets, training expenditures, and resource allocations to ensure efficient utilization of organizational resources while meeting departmental objectives.

• Lead, develop, and provide strategic direction to a team providing aseptic operations oversight spanning across four shifts, including personnel focused on training, coaching, and continuous improvement of aseptic processing.

• Build and expand aseptic operations expertise, governance, and oversight capabilities to support the successful implementation of new sterile manufacturing lines, technologies, and products at the facility.

• Champion continuous improvement initiatives to enhance aseptic operations performance, compliance, standardization, and operational excellence across the facility.

• Maintain a visible leadership presence within the aseptic manufacturing environment to reinforce compliance expectations, assess personnel performance, provide coaching, and support operational decision-making.

• Provide leadership support across all production shifts, as required, to ensure consistency in training execution, aseptic oversight, and organizational standards.

• Ensure compliance with all applicable Health, Safety, Environmental, Energy, Quality, and Regulatory Management System requirements and promote a culture of safety, quality, and compliance throughout the organization.

Job Requirements:

• Bachelor's degree in Microbiology, Biology, or a related scientific degree

• Minimum of 3 years of Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications.

• Industrial Certification and/or formal Training in Aseptic Operations a plus

• Thorough knowledge of cGMPs in a pharmaceutical environment

• Proven experience in FDA inspections and responses

• Ability to work weekends as needed.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.