Senior Manufacturing Systems Engineer
- Employer
- Amgen
- Location
- Holly Springs, North Carolina
- Start date
- Nov 8, 2024
View more categoriesView less categories
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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. 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.
Senior 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 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 PLCs. 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, 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, including remote and hybrid work arrangements, where possible
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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