Principal Validation Scientist-Aseptic Processing
Amgen - Municipio de Juncos, PR

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Manages and/or applies extensive technical validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of processes, systems or facilities. Provides strong technical guidance for the sustainability of the routine aseptic manufacturing operations and hands on validation / technical expertise to the drug product parenteral manufacturing operations with broad knowledge on media fill process simulation studies execution, air flow pattern studies, room design and their associated engineering and process interacting controls.


1. Establish validation engineering policies for a major segment of the company. (*)
2. Interpret, execute, and/or recommend modifications to company-wide policies. (*)
3. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project. (*)
4. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts. (*)
5. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept. (*)
6. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity. (*)
7. Plan, organize and coordinate work of a staff of engineers and/or technicians. (*)
8. Lead efforts with manufacturing, process development, utilities, facilities, labs, and /or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. (*)
9. Prompt and regular attendance to workplace. (*)
• Proven experience designing and conducting media fill simulation studies including the certification and re-certification of aseptic rooms implemented for the production of multiple sterile parenteral biological dosage forms
• Hands on experience designing, conducting and interpreting the outcome of air flow pattern studies (i.e. smoke profiles) intended to support the qualification of aseptic processing facilities, the introduction of new equipment, the evaluation of process changes and the simulation of new aseptic interventions within classified areas.
• Strong technical and compliance understanding on the elements associated to Sterility Assurance Level (SAL) and their applicability to the implementation and maintenance of aseptic processing programs as a center of excellence.
• Expert validation knowledge (equipment qualification, cleaning, sterilization).
• Is recognized as a leader and authority in company in broad area of specialization or intensely specialized field.
• Global/Multi Site Lead for large or complex or business critical project).
Problem Solving:
• Provide technical validation solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
• Works under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results.
• Develops advanced technological ideas and guides their development into a final product.
Has full responsibility for interpreting, organizing executing and coordinating assignments.
• Supervision received is essentially administrative, with assignments given in broad terms concerning general objectives and limitations.
• Essential to the completion of corporate wide initiatives and programs.
• Decisions, recommendations and actions form the basis of corporate program schedules and personnel/fiscal resource utilization and affect the image of the organization’s technological capability.
* Other functions may be assigned.
Basic Qualifications
Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Preferred Qualifications
• Leads efforts of organization within functional boundaries, influences efforts of adjacent organizations.
• Expected to be capable of managing complex project objectives or multi-tiered organization.
• May be expected to directly supervise staff or project resources.
• Serves as organization spokesperson on advanced projects and/or programs. Acts as advisor to management and customers on advanced validation engineering studies and applications.
• Acts as a technical liaison to individuals within and outside the organization with responsibility to act independently regarding technical matters in individual's field.
• Comprehensive understanding of regulatory requirements and applications.
• Key expert and decision maker for validation compliance issues
* Other functions may be assigned.
• Knowledge of theories and principles related to leading edge technologies associated to drug product parenteral manufacturing and aseptic processing operations in general.
• Advanced technical expert in at least one specialty area. (Corporate level)
• Ability to motivate and communicate vision/direction of validation program
• Ability to influence validation program at a site/corporate level
• Demonstrated Skills in the following areas:
• Advanced project management
• Presentations to large groups
• External networking
• Personnel coaching and development
• Technical expertise areas of validation engineering.
• Ability to independently determine when additional external resources are required to solve problems
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools
• Ability to delegate and manage the project work of others
• Demonstrated Skills in the following areas:
• Negotiation, persuasion and facilitation
• Collaboration
• Project cost development
• Conflict Resolution
• Decision Making
• Leadership and teambuilding
• Management of contractors and vendors
• Capable to provide strong technical guidance in support to the sustainability of the routine aseptic manufacturing operations in terms of personnel flow, aseptic interventions execution and the management of unexpected events.
• Strong knowledge on aseptic techniques, gowning techniques, assembly of aseptic processing lines and room classifications.
• Knowledgeable on the technical concepts associated to clean rooms cleaning, sanitization, assembly and operation of aseptic production lines.
• Capable to establish aseptic process mappings and sterile systems boundary evaluations as key tools in the execution of robust and well integrated continuous improvement initiatives.
• Skillful conducting aseptic processing risk assessments associated to non conformance events and conducting expert validation assessment in support to change control initiatives.
• Proficient on aseptic processing regulatory and compliance related matters including demonstrated knowledge on current industry trends for media fills and smoke study executions.
• Basic understanding on the microbiological principles associated to aseptic processing.
• Hands on experience and technical understanding on isolation technologies and bio-decontamination processes highly desirable.
• Capable on presenting and defending the execution of media fills and air flow pattern related studies before regulatory agencies and to other internal and external regulatory and compliance authorities including site senior leadership and plant governance groups.

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