Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission, to serve patients, drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing & delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

What you will do

Let’s change the world. In this vital role you will independently manage and oversee complex Commissioning and Qualification activities within capital projects involving the planning, design, construction, and execution of manufacturing process equipment, facilities and utilities. You will lead a commissioning team leveraged from within the company and external partners, for complex, technical projects, to coordinate the implementation of highly innovative and ingenious solutions to support Amgen’s business needs.

Job Summary

Amgen recently announced plans to build a new 270,000 sf / $400M greenfield packaging facility in New Albany, OH. The Project has been funded and enabling works are in progress with construction to start in the fall of 2021 with a target completion date in 2024.

Amgen is searching for an experienced Commissioning and Qualification (C&Q) manager (reporting to the Project Director) to lead the C&Q scope of this new site. The C&Q lead will be responsible for delivering all aspects of the C&Q Program on site, including facilities, utilities, warehouse (ASRS & AGVs), and process (packaging & Assembly lines) equipment.  This includes front end planning, estimating, program setup, implementation, execution, and closure.  The Senior Manager is responsible for ensuring commissioning and qualification delivery meets the program requirements and is cost effective for Amgen.

This position will also drive operational improvement strategies, shares and incorporates best practices and lessons learned, and partners with key stakeholders.  The role will require local presence, therefore relocation near the job site (New Albany, Ohio) is essential.

As a permanent staff member there will be significant opportunities beyond this project for further career development through potential future site expansions, facility management opportunities once facility is operational as well as numerous opportunities across the Amgen network.

Other Responsibilities include:

• Assists GSS on scope of work definition of external contractors and reviews contractual documentation.

• Responsible for staffing projects with suitably qualified resources and providing guidance and oversight on program implementation.

• Prepares and keeps up-to-date the pre-commissioning and commissioning execution plans (including the schedule and the mobilization of personnel and equipment).

• Manages day to day Commissioning and Qualification activities including planning, staffing, schedule development and overall tracking and reporting of status and issues

• Directly manages execution of commissioning and qualification aspects of projects including C&Q document preparation, execution, and daily coordination

• Supervises the preparation of the pre-commissioning and commissioning procedures.

• Reviews engineering documents to ensure that the commissioning & startup requirements are accounted for in the design.

• Drive alignment of Commissioning and Qualification requirements with Engineering and Construction teams to ensure all aspects are aligned with the program including adherence to engineering specifications, Receipt Verification, Third Party Inspection, Walkdown and Turnover Planning, Turnover Package Documentation, and Engineering Change Management

• Ensures Amgen staff and Contingent workers on the Amgen Commissioning and Qualification Program are up to date with C&Q training requirements

• Manages the execution of pre-commissioning, commissioning and start-up activities.

• Prepares and provides commissioning progress reports

• Coordinates assistance of the Vendor representatives, as required.

Win

What we expect of you

Basic Qualifications

Doctorate degree and 2 years of Engineering or Commissioning and Qualification Management experience

Or

Master’s degree and 6 years of Engineering or Commissioning and Qualification Management experience

Or

Bachelor’s degree and 8 years of Engineering or Commissioning and Qualification Management experience

Or

Associate’s degree and 10 years of Engineering or Commissioning and Qualification Management experience

Or

High school diploma / GED and 12 years of Engineering or Commissioning and Qualification Management experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

We are all different, yet we all use our unique contributions to serve patients. The Engineering Projects professional we seek is a dynamic Sr Manager with the following preferred qualifications:

• Bachelor’s Degree in Engineering or related technical field

• 10+ years of experience in engineering project execution and commissioning management

• 6+ years direct supervisory experience

• 6+ years in the Pharmaceutical / Biotechnology industries

• Extensive knowledge and proven experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects, specially Packaging and/or Automated Supply and Retrieval Systems (ASRS)

• Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry

• Excellent communication skills

• Strong collaborator, problem solver and solution oriented

• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team- based environment.

• Extremely organized and thinks strategically to support key business decisions

• Ability to manage multiple tasks and effectively set priorities

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care of our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.