Manufacturing Execution Systems Specialist

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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-related conditions. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Execution Systems Specialist

What you will do

Lets do this. Lets change the this vital role within the B20 Drug Product manufacturing organization you will serve as a Manufacturing Execution System (MES) Subject Matter Expert (SME) supporting manufacturing operations lifecycle management and new product introductions (NPIs) at a Drug Product (DP) Manufacturing facility. This role is focused on design development validation and continuous improvement of Electronic Batch Records (EBRs) and MES capabilities to enable reliable compliant and efficient manufacturing processes.
You will act as a technical MES leader partnering cross-functionally with Manufacturing Process Development Supply Chain Quality and Engineering to ensure MES solutions align with business processes and regulatory requirements. This position will also contribute to network-wide MES standardization digital transformation and continuous improvement initiatives across the site and network with a strong emphasis on DP manufacturing processes (e.g. formulation filling inspection and packaging).

Key Responsibilities

• Design develop and maintain DP Manufacturing Electronic Batch Records (EBRs) using Körber PAS-X

• Translate DP manufacturing processes / user requirement specifications into compliant MES templates recipes and workflows

• Ensure EBRs and data reporting out of MES are robust efficient and aligned with GMP requirements

• Support validation activities for MES / EBRs including testing and defect resolution

• Provide day-to-day MES support to manufacturing operations including troubleshooting and on-call support

• Partner with NPI leads to enable MES readiness for New Product Introductions

• Support deployment of new MES capabilities and system integrations (SAP PI DeltaV Rockwell Kepware)

• Identify and implement improvements to MES design usability and performance

• Contribute to MES standardization and best practices across the site and network

• Support change control activities ensuring compliance with GMP procedures

• Collaborate cross-functionally and communicate MES-related updates effectively

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 2 years of Manufacturing Execution Systems experience OR

• Bachelors degree and 4 years of Manufacturing Execution Systems experience OR

• Associates degree and 8 years of Manufacturing Execution Systems experience OR

• High school diploma / GED and 10 years of Manufacturing Execution Systems experience

Preferred Qualifications:

• Hands-on experience with Körber PAS-X (EBR design and development)

• Experience with MES validation and lifecycle management in a GMP environment

• Strong technical writing and communication skills

• Strong familiarity with Drug Product manufacturing processes (formulation filling inspection packaging)

• Experience with system integrations (SAP PI DeltaV Rockwell Kepware)

• Familiarity with quality systems (change control deviations CAPA validation)

• Strong troubleshooting and analytical problem-solving skills

• Experience supporting NPIs from an MES perspective

• Ability to translate manufacturing processes / user requirements specifications into MES solutions

• Ability to manage multiple priorities in a fast-paced environment

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 well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

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.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range