Sr. Engineer Process Development (Commissioning, Qualification, and Validation)

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.

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.

**What you will do**

Let’s do this.

Let’s change the world.

In this role the Senior Engineer position reports to the Sr, Manager of Validation.

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 facility.

**Functions**

The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site.

The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise in the qualification and validation of combination products.

This position will also be required to apply advanced and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.

**Outputs**

**Project Management**

Key responsibilities will include supporting the **Qualification and Validation** of the Amgen product portfolio to AOH.

Additional responsibilities will include the provision of **technical operations support** for the **continuous improvement** of device assembly and packaging line capacity and performance, and advisory of technical improvement projects.

The Sr. Engineer must ensure effective communication throughout the Amgen Ohio commercial site and Amgen network with all stakeholders and deliver on technical deliverables.

**Technical Lead**

Act as the site technical expert for automated and semi-automated device assembly for FDP and non-combination **products** .

Be the technical expert for **new process and existing device assembly technology** .

The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

Technical expertise in combination product assembly is required.

The candidate will also be responsible for conducting the **Commissioning, Qualification and Validation** of process and GMP equipment located at AOH.

They will own the site master validation plan for GMP equipment and will be responsible for the maintenance and execution of this.

**Operational Excellence**

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients.

The CQV professional we seek will posses these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Master’s degree and 2 years of working in a GMP regulated environment

Or

Bachelor’s degree and 4 years of working in a GMP regulated environment

Or

Associate’s degree and 8 years of working in a GMP regulated environment

Or

High school diploma / GED and 10 years of working in a GMP regulated environment

**Preferred Qualifications:**

+ Knowledge of combination product assembly equipment and applicable testing.
+ Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
+ Proven track record of leading and executing cross-functional projects.
+ Strong teamwork, excellent interpersonal and communication skills.
+ Direct experience with the manufacturing process for devices, combination products and label & packaging operations.
+ Experience of working with Final Drug Product 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 moving environment.
+ An Operational Excellence 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:

+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation.

You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

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.

Required Skill Profession

Other General