Senior/Principal Manufacturing Asset Engineer, HTO jobs in United States
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Roche · 3 months ago

Senior/Principal Manufacturing Asset Engineer, HTO

Roche is a leading pharmaceutical company focused on delivering life-saving medicines. The Senior/Principal Manufacturing Asset Engineer will support the design, operation, control, and optimization of manufacturing equipment, ensuring compliance with Good Manufacturing Practices and contributing to continuous improvement activities.

BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Provide technical support and engineering solutions for process and equipment-related issues
Understand the basis for the qualification of equipment and ensure that the equipment / systems remain in their qualified state and in alignment with Good Manufacturing Practices and all relevant Roche standards
Collaborate with leadership to establish priorities, targets and milestones
Represent the department functionally, cross-functionally and cross-site for various activities and initiatives applying discretion to independently address issues or resolve problems
Provide on-floor support to the Manufacturing teams regarding equipment
Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned
Contribute to the development of maintenance strategies, asset monitoring strategies, asset life-cycle management strategies, qualification strategies, spare part stocking strategies, etc
Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment
Ensure any changes are documented appropriately through the change management system
Use data-driven analysis of process and equipment to understand performance and capacity
Identify, recommend, and implement improvements to optimize system performance
Ensure process operations comply with all health, safety, and environmental policies and procedures
Participate in Hazardous operations and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment

Qualification

Mechanical EngineeringCommissioningQualificationCapital Project ExecutionData AnalysisAseptic ProcessesTeam CollaborationOrganizational SkillsProblem Solving

Required

You have a B.S or higher in Mechanical Engineering, Electrical, Chemical, Biochemical, or related discipline
You have 8-11 years experience in the pharmaceutical or biotechnology industry for a Senior Engineer and 12+ for a Principal Engineer level
You are a self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision
You have a demonstrated success operating in teams (especially cross-functional teams)
You have strong organizational, computer, and analytical skills
You have experience in capital project design, development, and execution
You have an understanding of drug product and/or finished goods processes & equipment
You have experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
This position is eligible for relocation benefits

Company

Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.

H1B Sponsorship

Roche has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)

Funding

Current Stage
Public Company
Total Funding
$7.79B
Key Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M

Leadership Team

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Alan Hippe
Member of the Executive Board - Group CFO
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Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
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Company data provided by crunchbase