Engineer I
BioSpace
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Job summary
BioSpace is seeking an Engineer I to technically support manufacturing processes, secondary packaging operations, automated inspection systems, labeling technologies, and business applications. You will act as System Owner for assigned assets, ensuring qualification, compliance, and inspection-readiness throughout their lifecycle.
Responsibilities include supporting preventive maintenance, validation, change control, and lifecycle activities, while collaborating with Quality, Manufacturing,
Qualifications
- Master's degree or equivalent in engineering or related field.
- Bachelor's degree plus 2 years engineering experience or an Associate's + 4 years of engineering experience.
- High school diploma plus 6 years engineering experience.
Responsibilities
- Serve as the System Owner for assigned manufacturing systems, computerized systems, packaging equipment, facility assets, utilities, and infrastructure.
- Maintain assigned systems in a qualified, compliant, reliable, and inspection-ready state throughout their lifecycle.
- Develop, maintain, and update engineering documentation including specifications, engineering assessments, lifecycle documentation, and technical reports.
- Review and support preventive maintenance strategies, calibration programs, engineering changes, and system improvements.
- Monitor system performance and implement reliability, operational excellence, and continuous improvement initiatives.
- Maintain computerized systems in compliance with applicable regulatory requirements, including vulnerability assessments and system lifecycle documentation.
- Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives.
- Provide technical ownership of SAP-integrated operational systems supporting shipping interfaces, label printing, scale connectivity, report tracking and automated packaging workflows.
- Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements.
Skills
Education
Tools
Job description
Lets do this. Lets change the world. In this vital role you will technically support manufacturing processes, secondary packaging operations, automated inspection systems, labeling technologies, and business applications while ensuring assigned systems remain qualified, compliant, and inspection ready throughout their lifecycle.
The Engineer I serves as the System Owner for assigned assets and computerized systems, supporting engineering activities related to system reliability, lifecycle management, validation, change control, and operational excellence. The position collaborates closely with Quality, Manufacturing, Automation, Maintenance, Supply Chain, Information Systems, and Project teams to execute engineering activities in accordance with applicable regulatory requirements, corporate standards, and business objectives.
- Serve as the System Owner for assigned manufacturing systems, computerized systems, packaging equipment, facility assets, utilities, and infrastructure.
- Maintain assigned systems in a qualified, compliant, reliable, and inspection-ready state throughout their lifecycle.
- Develop, maintain, and update engineering documentation including specifications, engineering assessments, lifecycle documentation, and technical reports.
- Review and support preventive maintenance strategies, calibration programs, engineering changes, and system improvements.
- Monitor system performance and implement reliability, operational excellence, and continuous improvement initiatives.
- Maintain computerized systems in compliance with applicable regulatory requirements, including vulnerability assessments and system lifecycle documentation.
- Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives.
- Provide technical ownership of SAP-integrated operational systems supporting shipping interfaces, label printing, scale connectivity, report tracking and automated packaging workflows.
- Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements.
- Support manufacturing operations, secondary packaging processes, and shipping systems.
- Provide engineering support for labeling systems, barcode technologies, automated vision inspection systems, printers, scanners, and packaging automation.
- Troubleshoot technical issues affecting manufacturing and packaging operations while implementing sustainable engineering solutions.
- Support manufacturing process improvements that enhance equipment reliability, operational efficiency, and product quality.
- Perform technical investigations and root cause analyses using structured problem-solving methodologies.
- Support Change Control activities by performing engineering impact assessments, risk evaluations, and qualification assessments.
- Ensure engineering activities comply with GMP regulations, corporate engineering standards, and applicable regulatory requirements.
- Maintain documentation in accordance with Good Documentation Practices (GDP) and quality system expectations.
- Support capital projects, equipment upgrades, infrastructure improvements, and manufacturing system enhancements.
- Participate in project planning, design reviews, commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), qualification, startup, and project turnover.
- Author, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, engineering rationale documents, and validation summary reports.
- Review engineering designs and contractor deliverables to ensure compliance with regulatory, engineering, and business requirements.
- Coordinate validation and implementation activities with Engineering, Quality Assurance, Manufacturing, Automation, Supply Chain, and external contractors.
- Support project execution to achieve scope, schedule, budget, and quality objectives.
- Support implementation of SAP-integrated operational workflows and business process improvements.
- Support internal audits, customer audits, and regulatory inspections as the engineering subject matter expert for assigned systems.
- Present engineering documentation, validation packages, technical assessments, and qualification strategies during inspections.
- Support responses to audit observations and engineering-related quality actions.
- Maintain assigned systems and engineering documentation in a continuous state of inspection readiness.
- Partner with Quality, Manufacturing, Automation, Maintenance, Validation, Supply Chain, EHSS, and Information Systems to support site objectives.
- Collaborate with global engineering and technology teams during lifecycle projects and system deployments.
- Promote continuous improvement, operational excellence, and engineering best practices.
- Share technical knowledge and support the development of engineering solutions across functional teams.
We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a dynamic with these qualifications.
Masters degree
OR
Bachelors degree and 2 years of Engineering experience
OR
Associates degree and 4 years of Engineering experience
OR
High school diploma / GED and 6 years of Engineering experience
- Experience supporting GMP manufacturing or pharmaceutical operations.
- Knowledge of equipment lifecycle management and System Ownership principles.
- Understanding of GMP, data integrity, computerized system validation, and change control processes.
- Experience supporting manufacturing automation, packaging equipment, or industrial control systems.
- Experience participating in commissioning, qualification, and validation activities.
- Strong troubleshooting, analytical, and problem-solving skills.
- Excellent written and verbal communication skills with the ability to work effectively across cross-functional teams.
- SAP ERP
- ServiceNow
- Microsoft Windows Operating Systems (Windows 10/11)
- Zebra printers
- Domino printers
- Industrial barcode scanners
- Label printing systems
- Automated vision inspection systems
- Packaging automation equipment
- Manufacturing IT infrastructure
- Computerized System Validation (CSV)
- GMP documentation practices
- Technical problem solving
- System ownership and accountability
- Continuous improvement mindset
- Cross-functional collaboration
- Customer focus
- Attention to detail
- Regulatory compliance
- Project execution
- Communication and technical documentation
- Learning agility
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.
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.
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