Engineer II, Integration
Santa Clara County, CA - USA
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
How You Will Make an Impact:
The Engineer II Integration supports the integration configuration testing and commissioning of automation and bioprocessing systems within Product Engineering ensuring systems are accurately configured and prepared for Factory Acceptance Testing (FAT) and customer delivery. The role contributes to the transition from engineering requirements and system components to complete tested documented and supportable automation solutions ready for customer acceptance and delivery. This role independently executes assigned system-integration and configuration activities troubleshoots hardware software network and configuration issues and resolves technical problems within established engineering standards and procedures while collaborating cross-functionally to support system readiness reduce integration-related risks and improve execution.
Location: Santa Clara CA. Relocation assistance is NOT provided.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check which includes a drug screening.
What will you do:
- Review system architecture build definitions technical documentation and customer requirements to ensure assigned integration activities are executed accurately.
- Identify integration-related risks dependencies or schedule impacts and communicate or escalate issues appropriately to support project commitments.
- Build configure and verify assigned system infrastructure including servers virtual machines network settings system communications software configurations and related integration components in accordance with approved system architecture and established engineering requirements.
- Configure and verify assigned DeltaV TruBio HCI server network and automation-system components including system communications controllers I/O operator interfaces alarms/events historians user/security functions and other applicable features in accordance with approved system architecture and project requirements.
- Configure and verify assigned TruBio control areas and vessel configurations for applicable single-use equipment including process parameters instrumentation alarms interlocks engineering units ranges and customer-specific options in accordance with approved system requirements.
- Configure test and troubleshoot communications and interfaces between automation systems and single-use equipment controllers PLCs I/O instrumentation Modbus devices and supported third-party equipment.
- Configure and verify applicable operator graphics system navigation user access historians alarms/events and other operator-facing automation functionality.
- Independently execute assigned system-integration activities for standard and moderately complex customer configurations escalating highly complex or non-standard technical issues as appropriate.
- Maintain accurate and controlled system build records and complete required as-built documentation and system backups including applicable automation configurations controllers/I/O licensing information and supporting technical documentation in accordance with established procedures.
- Document technical issues troubleshooting activities configuration changes test results and resolutions accurately and in accordance with applicable engineering and quality requirements.
- Verify system configuration connectivity functionality documentation and overall readiness prior to Factory Acceptance Testing (FAT).
- Independently troubleshoot routine-to-complex hardware software network communications and configuration issues; apply structured problem-solving methods to identify root causes implement corrective actions within established technical standards verify effective resolution and escalate highly complex or systemic issues as appropriate.
- Prepare assigned systems for FAT customer acceptance shipment installation and subsequent service support by ensuring configuration documentation backups and required technical records are complete and accurate.
- Support FAT execution from an integration perspective by ensuring system readiness resolving assigned technical issues implementing approved configuration changes and coordinating with Validation Engineering and project stakeholders.
- Partner with Validation Manufacturing Engineering Product Engineering Project Management Manufacturing Service and other stakeholders to resolve integration issues and support project execution.
- Provide technical input during project discussions and customer-facing activities within assigned areas of responsibility.
- Support Service activities for installed systems expansions modifications backup/restoration and troubleshooting of assigned automation configuration networking communications and control-system issues.
- Support NPI activities by executing assigned integration configuration commissioning testing documentation and system-readiness activities for new equipment automation platforms and product enhancements; identify integration gaps and technical risks and communicate lessons learned to the appropriate Engineering stakeholders.
- Identify and implement improvements to integration procedures checklists technical documentation troubleshooting practices and standard workflows to improve quality repeatability cycle time and execution efficiency.
- Participate in or lead assigned PPI/continuous improvement activities within the scope of the role.
- Configure document and verify assigned automation-system features that support applicable GMP data-integrity and 21 CFR Part 11 requirements including user access/security audit trails alarms and events electronic records system history and other compliance-related functions as defined by system and customer requirements.
- Perform and independently execute assigned integration configuration testing and commissioning activities for automation and bioprocessing systems in accordance with approved system architecture customer requirements engineering documentation and project schedules.
- Support custom and non-standard system configurations under appropriate engineering direction and within established design requirements.
- Manage multiple assigned integration activities and project priorities while meeting established schedules and quality requirements.
- Share technical knowledge and provide informal guidance or peer support to colleagues within areas of demonstrated expertise.
- Perform other duties as assigned.
The responsibilities described above are representative of the nature and level of work performed and are not intended to be an exhaustive list of all duties and responsibilities.
Education & Experience:
Required:
- Advanced Degree in Engineering Computer Science Automation Controls or a related technical discipline; OR
- Bachelors Degree in Engineering Computer Science Automation Controls or a related technical discipline with 2 years of experience in supporting automation control systems system integration commissioning validation or other technically complex engineered systems; OR
- Associate Degree in Engineering Computer Science Automation Controls or a related technical discipline with 4 years of experience in supporting automation control systems system integration commissioning validation or other technically complex engineered systems; OR
- High School Diploma or equivalent with 6 years of experience in supporting automation control systems system integration commissioning validation or other technically complex engineered systems.
- Experience configuring integrating testing or commissioning automation control computer/network or other technically complex systems.
- Experience troubleshooting hardware software network communications or system-configuration issues.
- Experience working with technical documentation system architectures configuration requirements or test procedures.
- Experience working cross-functionally within engineering manufacturing validation service or project environments.
Preferred:
- Experience with DeltaV TruBio HCI PLC/SCADA or comparable industrial automation/control platforms.
- Experience with virtualization technologies servers networking and system infrastructure.
- Experience configuring or troubleshooting industrial networks communications and integrated automation systems.
- Experience supporting Factory Acceptance Testing (FAT) commissioning system qualification or validation activities.
- Experience with single-use bioprocessing equipment bioreactors mixers or related capital equipment.
- Experience in biotechnology pharmaceutical medical-device or other GMP-regulated manufacturing environments.
- Experience supporting customer-configured or engineer-to-order systems.
Knowledge Skills Abilities:
Required:
- Strong working knowledge of automation and system-integration principles applicable to industrial or bioprocessing equipment.
- Working knowledge of automation platforms control systems servers virtualization networking communications instrumentation and integrated system architectures used in industrial or bioprocessing applications.
- Working knowledge of system configuration user access/security alarms/events historians control-system interfaces and other automation features applicable to assigned systems.
- Ability to independently configure integrate test and troubleshoot assigned automation and system components within established engineering standards and procedures.
- Strong technical troubleshooting and problem-solving skills with the ability to diagnose hardware software network communication and configuration issues.
- Ability to understand and interpret system architectures network diagrams and configurations server/virtualization environments technical specifications configuration requirements test procedures and engineering documentation sufficient to configure integrate test and troubleshoot assigned systems.
- Ability to identify technical risks dependencies and configuration issues and escalate non-routine or high-impact issues appropriately.
- Ability to perform and verify approved system backup and restoration activities for assigned automation configurations and supporting system components.
- Strong attention to detail and commitment to system configuration accuracy documentation quality and repeatable execution.
- Strong organizational and prioritization skills with the ability to manage multiple assigned projects and integration activities.
- Effective cross-functional communication skills with the ability to collaborate with Engineering Validation Manufacturing Project Management Service and other stakeholders.
- Ability to communicate technical issues troubleshooting findings risks and recommendations clearly to technical and non-technical stakeholders.
- Ability to work independently within established engineering standards procedures and technical direction.
- Ability to document system configurations test results troubleshooting activities and technical resolutions accurately.
- Ability to share technical knowledge and provide peer guidance within areas of demonstrated expertise.
- Working knowledge of applicable quality safety configuration-management and regulated-environment requirements.
- Working knowledge of GMP data-integrity 21 CFR Part 11 quality-system and validation requirements applicable to automation and control systems.
- Proficiency with applicable engineering automation configuration documentation and Microsoft Office/business systems.
Preferred:
- Knowledge of DeltaV TruBio HCI PLC/SCADA or related automation platforms.
- Knowledge of Windows Server virtualization technologies networking TCP/IP and related infrastructure.
- Familiarity with industrial communication protocols and network architectures.
- Knowledge of FAT commissioning validation and equipment qualification practices.
- Knowledge of single-use bioprocessing equipment and related technologies.
- Familiarity with Lean Manufacturing PPI or continuous improvement methodologies.
Physical Requirements and Work Environment:
- Combination of office-based engineering work and regular activity within integration laboratory FAT manufacturing and testing areas.
- Regular use of computers automation systems engineering/configuration tools and business systems for extended periods.
- Frequent standing and walking within integration and FAT areas to configure test troubleshoot and evaluate systems.
- May require bending reaching crouching or accessing equipment control panels servers network hardware cables or system components during integration and troubleshooting activities.
- Required use of appropriate PPE when entering designated manufacturing laboratory integration testing or controlled areas.
- Exposure to electrical equipment automation hardware manufacturing equipment and moderate noise levels as applicable to the work environment.
- Occasional lifting or movement of tools cables components computer/network equipment or related materials up to 25 lbs.
- Role requires regular onsite presence to support system integration testing FAT activities and project execution.
- May require schedule flexibility to support FAT activities project deadlines system troubleshooting customer commitments or other business-critical activities.
Apply today!
We offer competitive remuneration annual incentive plan bonus scheme healthcare company 401k and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform critical job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Compensation and Benefits
The salary range estimated for this position based in California is .This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more