Mfg. Systems Engineer - Automation Engineer
Initial Therapeutics, Inc.
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Benefits offered by this job
Job summary
Amgen, located in New Albany, Ohio, seeks a Manufacturing Systems (Automation) Engineer to design and implement automation for packaging systems and to lead major automation projects on a 24-hour operation.
The role requires strong automation knowledge, project leadership, and experience with GMP/FDA standards. It offers growth within a collaborative, science-driven environment at Amgen.
Qualifications
- Master's degree or equivalent in Engineering or related field.
- Bachelor's degree plus 2 years automation experience in pharma/biotech/medical devices.
- Associates degree plus 6 years automation experience in relevant industries.
- High school diploma with 8 years automation experience in relevant industries.
Responsibilities
- Design and develop automation systems for packaging machinery.
- Implement PLCs and HMIs and maintain technical documentation.
- Lead automation projects with cross-functional teams from planning to completion.
- Ensure compliance with FDA, GMP, and industry best practices.
- Provide training and ongoing support to operations and maintenance teams.
Skills
Education
Tools
Job description
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.
Lets do this. Lets change the world. At Amgen we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem-solving, leading to better solutions that benefit both patients and society.
Based in New Albany, Ohio, the site of Amgens new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects.
The work schedule for this role will be a 12-hour, 6 PM to 6 AM, 2-2-3 schedule (to support coverage across Amgens 24-hour operations). These shift structures can be a great opportunity to better support individual work/life priorities.
- Design and develop automation systems and control strategies for packaging machinery and processes.
- Implement and configure Programmable Logic Controllers (PLCs), Human-Machine Interfaces (HMIs), and other automation equipment.
- Create and maintain detailed documentation, including system specifications, design documents, and operational procedures.
- Integrate new automation technologies and equipment into existing packaging systems.
- Optimize control processes to enhance efficiency, reduce waste, and improve product quality.
- Conduct feasibility studies and cost-benefit analyses for automation projects.
- Diagnose and resolve issues with automation systems and control equipment.
- Provide technical support and troubleshooting for production and maintenance teams.
- Perform system upgrades and maintenance to ensure optimal performance and reliability.
- Ensure that all automation systems comply with FDA regulations, GMP standards, and industry best practices.
- Collaborate with Quality Assurance and regulatory teams to address any compliance or quality issues related to automation.
- Lead and manage automation projects, including planning, execution, and monitoring.
- Coordinate with cross-functional teams to ensure timely and successful project completion.
- Prepare and present project reports, performance metrics, and technical documentation.
- Train and support staff on the use and maintenance of automation systems.
- Develop training materials and conduct workshops to enhance team competency in automation technologies.
The position is a key role in the Engineering and Maintenance department and the candidate must manage and apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and processes. 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 characterization, optimization, scale up or manufacturing support projects.
Key responsibilities will include working with the engineering and maintenance team to support the commercial production packaging lines. Additional responsibilities will include providing technical operations support for continuously improving the packaging lines' capacity and performance and advising on technical improvement projects. The Engineer must ensure effective communication throughout the Amgen commercial site network with all stakeholders and deliver on technical improvements.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications:
- Masters degree
- Or
- Bachelors degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
- Or
- Associates degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
- Or
- High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
- Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
- Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
- Knowledge in Data Integrity and Security
- Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
- Proficiency in Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platform
- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
- Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
- Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
- Excellent communication (verbal/written) and presentation skills
- Demonstrated interpersonal skills, including: collaboration, influencing, and facilitation
- Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context
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
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.
Sponsorship for this role is not guaranteed.
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.
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