Sr Manufacturing Systems Engineer - New Albany, OH

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

What you will do

Let's do this. Let's change the world. In this role you will report into the Senior Manager Engineering under Packaging Operations Development at the Amgen Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio manufacturing facility.

The position is expected to travel for approximately 25%.

Based in New Albany, Ohio, the site of Amgen's new advanced product assembly and packaging plant this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.

Responsibilities:

Develop, organize, analyze and present interpretation of results for operational issues or engineering projects of significant scope and complexity

Complete sophisticated or novel assignments requiring development of new and/or improved engineering techniques and procedures.

Develop detailed specification and engineering policies and procedures that affect multiple organizational units.

Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.

Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.

Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

Coordinate the work of consultants, architects and engineering firms on development of standard design documents.

Additional Qualifications/Responsibilities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master's degree & 2 years of engineering experience in a GMP environment

Or

Bachelors degree & 4 years of engineering experience in a GMP environment

Or

Associate degree & 8 years of engineering experience in a GMP environment

Or

High school diploma / GED and 10 years of engineering experience in a GMP environment

Preferred Qualifications:

Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering

Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations

Knowledge in Data Integrity and Security

Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies

Expertise in Machine Vision (Cognex) and Rockwell software platform

Knowledge in Deep Learning

Direct experience with leading and managing Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices.

Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment

Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations

Excellent communication skills together with ability to work in a team environment.

Organizational, project management, problem-solving, as well as validation protocol and technical writing capability

Track record of leading and executing multi-functional projects.

Strong teamwork, excellent interpersonal and communication skills.

Direct experience with medical devices/combination products and associated manufacturing processes.

Experience in working with third-party vendors and equipment suppliers.

Ability to work in a highly regulated and ever-changing industry.

Ability to learn and rapidly adapt to new requirements in a fast paced environment.

An Operational Excellence and Lean Transformation approach to work product - driving rapid results.

A passion to deliver an excellent work product and develop others with an infective positive attitude!

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

Salary Range

142,955.00 USD - 162,947.00 USD