Principal Engineer

Thousand Oaks, CA
Mar 22, 2019
Required Education
Position Type
Full time
The Principal Engineer will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Amgen Thousand Oaks site.

Responsibilities include:
  • Provide technical leadership using engineering principles and drive forward projects varying from functional area projects focused on improving process equipment/utilities/facilities -to- large/complex capital projects to integrate new drug product manufacturing technologies into clinical/commercial facility. Leverage engineering expertise within the company and industry best practices, compliance with pertinent environmental health and safety practices, and aligning with evolving regulatory expectations and internal quality standards to implement new equipment and/or equipment/utility/facility modifications.
  • Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects ( $3M) e.g. facility construction, new equipment integration into clinical/commercial facility. This includes ensuring effective communication flow between cross-functional teams (e.g. F&E, Manufacturing, Quality, Project controls, project management, EHSS) and functional management, leading the selection of contractors for C&Q execution, managing their training and performance, C&Q deliverables and schedule to meet project timelines, and ensuring compliance with Amgen safety, C&Q and Quality standards.
  • Manage the portfolio of improvement/innovation projects within the F&E drug product engineering group using strategic approaches and resource prioritization.
  • Serve as SME in drug product process equipment, mentor peers in complex problem solving, driving best practices and technical advancement
  • Lead Class 2 Non-conformance investigations tied to equipment performance in a cross-functional team setting involving engineering, maintenance, manufacturing, process development, quality.
  • Manage NCs/CAPAs within the plant engineering team to ensure appropriate actions are identified in the records to address the root causes as well as on-time closure of the records
  • Establish and maintain strategic partnerships with equipment vendors as well as Amgen Network to stay informed on new equipment technologies and ancillary instruments/safety interlocks systems to identify opportunities, assess and implement innovation
  • Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits.

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

Master's degree and 6 years of Engineering experience
Bachelor's degree or and 8 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications
  • Bachelor's degree in Engineering (Chemical or Mechanical), Biotechnology
  • 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
  • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as filling (T/P as well as peristaltic), isolators, lyophilization, cappers, inspection as well as other equipment and utilities needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, tunnels, clean steam, water for injection, etc. Knowledge of SU systems and assemblies.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
  • Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
  • Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
  • Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
  • Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
  • Strong leadership, technical writing, and communication/presentation skills
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
  • Up to 10% domestic/international travel