Principal Manufacturing Systems Engineer

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Amgen is seeking a Principal Manufacturing Systems Engineer to lead IS/Automation initiatives across a cutting-edge drug substance manufacturing plant. You will drive portfolio planning, risk management, and cross-functional collaboration to deliver advanced manufacturing solutions.

The role requires deep expertise in PCS/MES platforms, validation, and change control, with a focus on ensuring systems meet stringent industry standards.

Qualifications

• Doctorate or Master's or Bachelor's or Associate's or High school with extensive IS/automation experience.
• Experience in manufacturing environments and with PCS/MES systems.
• Experience with validation and change control methodologies.

Responsibilities

• Own the successful delivery of varied IS/Automation projects with portfolio planning, resource and risk management.
• Evaluate and resolve multiple project issues using technical, PM, and business expertise.
• Cross-system assessments, feasibility analysis, scope projects, prioritize work, and recommend solutions.
• Translate opportunities into executable plans aligned with standards and business needs.
• Manage relationships with IS service owners, business partners and vendors.
• Communicate issues and proposed solutions to multiple levels of the organization.
• Elicit and analyze business needs and convert them into functional design.

Skills

Leadership

Communication

Collaboration

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Emerson DeltaV

Rockwell FactoryTalk

Rockwell PLCs

Aveva PI Data Historian

Kneat C&Q

Korber MES

Job description

Join Amgens Mission of Serving Patients

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

Since 1980, we’ve 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 and obesity-related conditions. 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.

Principal Manufacturing Systems Engineer

What you will do

Lets do this. Lets 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 a Principal Manufacturing Systems Engineer, you will:

• Own the successful delivery of varied portfolio of IS/Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by using technical, project management, and business expertise.
• Performs cross system assessments, feasibility analysis, scope projects, prioritize work you’re doing, and recommend optimal solution. Manage multiple initiatives and priorities.
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
• Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors.
• Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
• Accountable to elicit and analyze needs identified by business customers and convert them into functional design.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing technology professional we seek is an innovator with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Information Systems, Manufacturing Process automation/Information system experience
• OR
• Master's degree and 4 years of Information Systems, Manufacturing Process automation/Information system experience
• OR
• Bachelor's degree and 6 years of Information Systems, Manufacturing Process automation/Information system experience
• OR
• Associate's degree and 10 years of Information Systems, Manufacturing Process automation/Information system experience
• OR
• High school diploma / GED and 12 years of Information Systems, Manufacturing Process automation/Information system experience

Preferred Qualifications:

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Experience with the following product platforms: Automation/Process Control System (PCS), Data Historian and/or Manufacturing Execution System (MES) and/or laboratory systems and/or IS platforms.
• Position requires an in-depth knowledge and hands‑on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLCs. Aveva PI Data Historian knowledge is required.
• Kneat platform based C&Q documentation development knowledge a plus
• Additional experience with Korber MES is a plus.
• 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.
• Exposure to sophisticated technologies around PAT, APC, AR/VR, Location tracking, Control tower, IIoT, IDA and so on would be an advantage.
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11
• Experience with validation and change control methodology.
• Hands‑on experience with computerized systems including troubleshooting, reliability and performance improvements.
• Good interpersonal skills with ability to work collaboratively in a team-based environment.
• Understanding of cyber security and manufacturing network principles as applied to operations technologies.
• Demonstrate ability to lead and influence multi-functional teams and embrace a team-based culture.

What you can expect of 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 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

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.