Auto req 13823BR
Job Posting Title Sr Engineer - Mfg Projects
Career Category Operations
Employee Subgroup Salaried FT
Country (State/Region) United States - Colorado
Location (City) Boulder
Amgen Job Description Amgen Colorado’s Engineering team is responsible for delivering capital and expense improvement projects to our client’s business needs. We target small to moderate sized projects located within operating business units. We feature staff with diverse engineering backgrounds with intimate knowledge of operations and working in GMP environments. We minimize impact to client operations due to excellent planning, coordination, and controls.
The Sr. Engineer is responsible for engineering design, implementation, construction support, technical execution and commissioning for multiple capital and expense projects at Amgen Colorado. This involves preparation of engineering studies, conceptual design alternatives, schematic and design details, and commissioning protocols.
• Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects.
• Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements.
• Responsible for identifying and refining design alternatives during conceptual schematic design evaluations.
• Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases.
• Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation).
• Responsible for turnover packages prepared during the detailed design phase and project close out.
• Responsible in ensuring that all Amgen standards and procedures are followed by the project team.
• Verifies that all change control procedures are properly documented.
• Works closely with other discipline and/or project engineers to coordinate the design and implementation.
• May work in as a discipline or project engineer depending on the needs of each project.
Basic Qualifications • Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience
Preferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment.
Demonstrated understanding of project life cycle, versatility, adaptability, decision making skills, collaboration, accountability, problem solving skills, teamwork, and quality control on engineering projects. Position requires excellent technical writing and verbal communication skills.
Demonstrated track record of being science-based, competing intensely and winning, creating value for patients, staff and stockholders, being ethical, trusting and respecting each other, working in teams, ensuring quality, and collaborating, communicating, and being accountable.
? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired.
? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired.
? Demonstrated leadership experience
? Project management experience
? Technology transfer experience
? Knowledge of cGMP pharmaceutical manufacturing process design requirements.
? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA).
? Ability to review and approve engineering documentation such as requirements and design documents, I/O diagrams, one-line diagrams, panel layout diagrams, system architecture diagrams, and instrument data sheets.
