Summary:

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Functions (General):

1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.

*Other functions may be assigned

Design Engineering:

1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

Education:

• Masters + 2 years of Engineering experience.
• Bachelors in Engineering + 4 years of Engineering experience.

Preferred Qualifications:

•  Experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls. Initiate, revise, and approve manufacturing-controlled documents in the document management system. Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
• Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals. Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development. Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
• Assist in the development and execution of process validation protocols and reports. Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire). Ensure configurations align with process design, GMP requirements, and Amgen guidelines. Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
• Use Application Life Cycle Management (ALM) system during validations and navigate SAP for master data, process orders, production versions, inventory, and bill of materials (BOMs). Ensure SAP-MES PAS/X connectivity, troubleshoot IDoc communication issues, and maintain alignment between SAP and MES configurations, particularly for BOM accuracy and process integration.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support. Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.

Skills:

1. Working knowledge of pharmaceutical/biotech processes.
2. Familiarity with validation processes.
3. Familiarity with documentation in a highly regulated environment.
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope.

Demonstrated skills in the following areas:

• Problem solving and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.

Demonstrated Skills in the following areas:

• Basic technical presentations o Personal Organization o Validation Protocol Writing.
• Dealing with and managing change o Technical (Equipment Specific).
• Analytical Problem Solvingo Computer Literacy.
• Specialized equipment/process expertise.
• In-depth knowledge of validation processes and requirements as applied to new equipment installations.
• Interacts effectively with variety of communication and working styles.
• Ability to independently determine when additional internal resources are required to solve problems.
• Ability to handle multiple projects at one time.

Demonstrated Skills in the following areas:

• Schedule development o Facilitation
• Collaboration
• Basic project management o Completion and follow-up
• Established expertise in at least 3 separate areas of engineering technology.
• 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
• Leadership and teambuilding
• Management of contractors and vendors

Work Methodology:

• 100%-On Site
• 10 months (1st Contract)
• Administrative Shift (weekends and overtime may also be required)
• Professional Service Contract