Project/Equipment Engineer

at  Amgen

The Project / Equipment Engineer reports to the Senior Manager for Facilities & Engineering Projects and is responsible for portfolio ownership, scoping and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs.

Key Responsibilities

• Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion.
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Coordination of engineering readiness scoping and readiness for new product introductions.
• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and commercial operational readiness.
• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
• Ability to translate strategic/emerging technology solutions into pragmatic executable plans
• Development and management of change controls
• Participate as a member of multidisciplinary site and multisite teams
• Development of detailed specifications, engineering documents, protocols and standard operating procedures
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
• Support a safe working environment by complying with environmental health/safety practice, rules and regulations
• Travel may be required to support execution of projects.

Experience and Qualification:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
• Typically, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.
• Device assembly / Packaging Experience preferred.
• Technology transfer experience preferred.
• Proven project management experience.
• Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• Experience in MS Office, MS Project, Change Control & Document Management Systems
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills
• Data driven decision maker
• Ability to work to tight deadlines in a fast-moving environment.

• Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion.
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Coordination of engineering readiness scoping and readiness for new product introductions.
• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and commercial operational readiness.
• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
• Ability to translate strategic/emerging technology solutions into pragmatic executable plans
• Development and management of change controls
• Participate as a member of multidisciplinary site and multisite teams
• Development of detailed specifications, engineering documents, protocols and standard operating procedures
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
• Support a safe working environment by complying with environmental health/safety practice, rules and regulations
• Travel may be required to support execution of projects