Career CategoryProcess Development
Job DescriptionSr. Validation Scientist AML14 - Aseptic ValidationWhat you will doLet's do this. Let's change the world! In this vital role, you will provide expert technical leadership and hands-on validation support for aseptic drug product manufacturing operations across AML. You will lead and support aseptic process simulations, airflow visualization studies, Environmental Monitoring Performance Qualifications, validation strategies, investigations, process changes, new product introductions, and facility or equipment modifications.
As a Subject Matter Expert in Aseptic Validation, you will collaborate across Manufacturing, Engineering, Process Development, Facilities, Utilities, Microbiology, Environmental Monitoring, Quality Control, and Quality Assurance to ensure validation activities are scientifically sound, risk-based, compliant, and completed on schedule. You will also troubleshoot complex validation issues, support the continued qualified state, contribute to the Contamination Control Strategy and validation standards, and represent the organization during technical reviews, audits, and regulatory inspections.
Specific ResponsibilitiesResponsibilities include, but are not limited to:
- Provides independent technical guidance and hands-on aseptic process validation support for parenteral drug product manufacturing operations.
- Supports the qualification, continued control, and improvement of aseptic processes, equipment, facilities, utilities, laboratories, and supporting systems.
- Develops and implements validation strategies for new product introductions, process and equipment changes, facility modifications, capital projects, and other complex technical assignments.
- Applies advanced validation principles, scientific judgment, and risk-based approaches to address complex aseptic processing and validation challenges.
- Authors, reviews, and approves validation master plans, protocols, reports, risk assessments, periodic reviews, and other supporting technical documentation.
- Ensures validation activities and documentation comply with cGMP requirements, approved procedures, regulatory expectations, and applicable industry standards.
- Develops, plans, coordinates, executes, and evaluates aseptic process simulations, including media fills designed to represent routine operations, interventions, and worst-case manufacturing conditions.
- Plans, coordinates, executes, and evaluates airflow visualization studies in Grade 5 and other critical aseptic processing areas, including assessment of first-air protection, personnel practices, interventions, equipment configurations, and contamination risks.
- Supports the development, execution, and maintenance of science- and risk-based Environmental Monitoring Performance Qualification strategies for new, modified, and existing classified manufacturing areas.
- Reviews and interprets media fill, airflow visualization, EMPQ, environmental monitoring, cleanroom qualification, and related validation data to assess aseptic process performance and the state of contamination control.
- Assesses the effect of process, equipment, facility, HVAC, cleaning and disinfection, personnel practices, material flows, maintenance activities, and operational changes on the validated or qualified state.
- Determines validation, requalification, additional monitoring, remediation, or repeat-study requirements based on changes, deviations, adverse trends, or unexpected results.
- Troubleshoots systemic aseptic processing and validation issues and leads or supports investigations, root-cause analyses, impact assessments, CAPAs, and remediation activities.
- Provides aseptic validation assessments and technical input for change controls, deviations, nonconformances, CAPAs, audit observations, and other Quality Management System records.
- Collaborates with Manufacturing, Process Development, Engineering, Facilities, Utilities, Laboratories, Environmental Monitoring, Microbiology, Quality Control, Quality Assurance, and other applicable functions.
- Works with project managers and multidisciplinary teams to complete validation deliverables for engineering projects, facility modifications, capital projects, and new product introductions within schedule, budget, quality, and compliance requirements.
- Develops or contributes to validation policies, procedures, standards, and technical practices that may affect multiple departments or organizational units.
- Provides technical direction, training, coordination, and review of work performed by validation scientists, contractors, consultants, vendors, and project team members, as assigned.
- Supports the development, implementation, maintenance, and periodic review of the site Contamination Control Strategy from an aseptic process validation perspective.
- Participates in technical and governance forums, including the Environmental Control Network, Aseptic Council, Contamination Control Network, and other committees, as assigned.
- Supports continuous improvement initiatives related to aseptic processing, validation, environmental control, and contamination prevention.
- Identifies and escalates significant quality, compliance, supply, operational, and safety risks to appropriate management.
- Presents validation strategies, study results, conclusions, risks, and recommendations to technical teams, governance forums, senior management, auditors, and regulatory inspectors.
- Supports internal and external audits, regulatory inspections, and responses to audit or inspection observations.
- Maintains timely and regular attendance and complies with applicable site safety, quality, and operational requirements.
What we expect of you We are all different! Yet, we all use our unique contributions to serve patients. The Sr. Validation Scientist professional we seek is a Quality-driven professional with these qualifications:
Basic QualificationsDoctorate degree
OR
Master's degree & 3 years of Validations and Quality experience
OR
Bachelor's degree & 5 years of Validations and Quality experience
OR
Associate's degree and 10 years of Validations and Quality experience
OR
High school diploma / GED and 12 years of Validations and Quality experience
Preferred Qualifications- Bachelor's degree in Engineering, or a related technical discipline.
- Advanced knowledge of aseptic processing, including microbiological principles, aseptic techniques, gowning practices, cleanroom classifications, sterile-system boundaries, and the assembly and operation of aseptic manufacturing lines.
- Demonstrated experience with aseptic process simulations, including media fill strategy, execution, interventions, data assessment, and applicable regulatory and industry expectations.
- Demonstrated experience planning, executing, or evaluating airflow visualization studies and Environmental Monitoring Performance Qualification activities in classified manufacturing areas.
- Strong knowledge of cleanroom operations and contamination-control practices, including cleaning and disinfection, environmental control, personnel and material flows, and aseptic process mapping.
- Experience establishing sterile-system boundaries and performing risk assessments to support validation, investigations, process improvements, and contamination-control initiatives.
- Hands-on experience with isolator technology, barrier systems, and decontamination processes is highly desirable.
- Broad validation knowledge, including the development and approval of Validation Master Plans, risk assessments, protocols, test scripts, and completion or summary reports.
- Knowledge of current regulatory requirements, inspection trends, and industry practices related to aseptic processing, media fills, airflow visualization, environmental monitoring qualification, contamination control, and validation.
- Experience interacting with regulatory authorities and supporting regulatory inspections is preferred.
- Proficiency with electronic quality, laboratory, maintenance, manufacturing, validation, and documentation systems such as CDOCS, Kneat, LIMS, Maximo, MES, SAP, or equivalent platforms.
- Full professional proficiency in English and Spanish is preferred.
- Availability to work rotational shifts, nonstandard hours, and weekends when required to support validation studies and manufacturing-floor activities.
Competencies and Skills- Demonstrates considerable independence, technical judgment, and accountability when defining approaches, resolving issues, and determining resource needs.
- Applies scientific and engineering principles, calculations, hypothesis development, and creative analytical approaches to solve complex technical problems.
- Manages multiple priorities, projects, schedules, costs, milestones, and deliverables while meeting quality, compliance, and business requirements.
- Applies working knowledge of project management and financial concepts, including schedule development, cost estimation, budget planning, resource allocation, and follow-up.
- Leads multidisciplinary teams and effectively delegates, coordinates, and reviews the work of peers, assigned staff, contractors, consultants, and vendors.
- Identifies and engages appropriate internal and external resources to support technical problem-solving and project execution.
- Demonstrates strong leadership, decision-making, negotiation, influencing, facilitation, conflict-resolution, and team-building skills.
- Communicates effectively through technical writing, presentations, and verbal interactions with diverse internal and external stakeholders.
- Builds productive working relationships across functions and adapts effectively to different communication and working styles.
- Represents the organization as a technical specialist or primary technical contact for aseptic validation programs, major projects, audits, and regulatory matters.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
SponsorshipSponsorship for this role is not guaranteed.
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