Sr Project Engineer

Career Category

Engineering

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas
-Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer

What you will do

Let's do this. Let's change the world. In this vital role you will working in partnership with Facilities & Engineering, maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices.

This position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO).

* Be individually accountable for the deliverables on projects.

* Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

* Develop and present project charters/strategies to leadership.

* Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.

* Leads team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation process.

* Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

* Assist in development and review of User Requirements Specifications (URS).

* Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.

* Partnering with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).

* Recommend, evaluate, and manage performance of contract resources.

* Provide oversight for verification deliverables developed by outsourced/contract verification staff.

* Act as a liaison between cross-functional teams during project planning, execution, and closeout

* Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

* Ensure safety during commissioning, validation, maintenance and manufacturing activities

* Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of…