Senior Manufacturing Systems Engineer

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 136,000 - 159,000; Full time

Benefits offered by this job

Total Rewards Plan

Remote/hybrid work arrangements

Comprehensive medical/dental/vision

Job summary

Amgen seeks a Senior Manufacturing Systems Engineer to join its information systems team, supporting manufacturing operations for drug substances. You will work with SMEs to translate process needs into automated solutions and lead projects integrating new technology across utility and equipment platforms.

You will collaborate on system validation, QA alignment, and continuous improvement, with opportunities for remote/onsite collaboration in a fast-paced biotech setting.

Qualifications

• Advanced degree or years of experience in manufacturing process automation/information systems.
• Broad knowledge of automation design and process control in pharma/biotech environments.
• Experience with GMP-compliant validation and life cycle documentation.

Responsibilities

• Collaborate with SMEs to translate process requirements into automated solutions.
• Partner with stakeholders to improve workflow and productivity.
• Lead projects to integrate new drug substance manufacturing technologies.
• Support NPI and new technology introductions with automation assessments.
• Develop specifications and policies affecting multiple units.
• Document delivered solutions and support PQ in a GxP environment.
• Manage multiple initiatives with strong issue-resolution and timelines.

Skills

Automation design

Process control engineering

GMP knowledge

Documentation

Leadership

Education

Doctorate degree

Master's degree + 2 yrs experience

Bachelor's degree + 4 yrs experience

Associate's degree + 8 yrs experience

High school diploma / GED + 10 yrs experience

Tools

Emerson Delta-V DCS

Rockwell FactoryTalk

Aveva PI Data Historian

Job description

Career Category

Information Systems

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.

Senior Manufacturing Systems Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

As aSenior Manufacturing Systems Engineer,you will:

• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Ability to anticipate, evaluate and resolve project issues, delays, and problems by using technical, project management, and business expertise. Manage multiple initiatives and priorities.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively

What we expect of you

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

Basic Qualifications:

• Doctorate degreeOR
• Master's degree and 2 years of Manufacturing Process automation/Information system experienceOR
• Bachelor's degree and 4 years Manufacturing Process automation/Information system experienceOR
• Associate's degree and 8 years of Manufacturing Process automation/Information system experienceOR
• High school diploma / GED and 10 years of Manufacturing Process automation/Information system experience

Preferred Qualifications:

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software packages.
• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, and Process Control System Virtual Infrastructure design and implementation.
• Demonstrable understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Position requires an in-depth knowledge and hands-on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLC’s. Aveva PI Data Historian knowledge is preferred.
• Kneat platform-based C&Q documentation development knowledge a plus
• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.

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

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.

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.

Salary Range

135,728.00 USD - 159,431.00 USD