Senior Manager Manufacturing Engineering at Thermo Fisher Scientific

West Hills, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s or master’s in engineering (e.g., Electrical, Mechanical, Automation, or equivalent)
8+ years of experience in automation engineering
5+ years in people management roles
Demonstrated experience with automation in diagnostics, medical devices, or life sciences manufacturing
Knowledge of regulations (FDA, 21 CFR Part 820, Part 11, ISO 13485, IVDR, ISO 17025)
Project management experience (a plus)
Process Engineering experience (a plus)
Six Sigma experience (a plus)

Responsibilities

Develop and implement a world-class automation roadmap for diagnostic product manufacturing
Provide technical leadership for the selection and integration of physical automation platforms (e.g., robotic liquid handling systems, industrial filling and packaging, robotic packaging, SCADA)
Champion standardization, modularity, and scalability of automation solutions
Lead, train, and mentor the team through Practical Process Improvement (PPI)
Identify areas for improvement and cost savings through equipment lifecycle management
Coordinate end-to-end automation projects—from concept, justification, timelines, budgets, prioritisation, URS generation, vendor selection, design/build, FAT/SAT, installation, CQV
Drive improvements in efficiency, repeatability, and data integrity through automation upgrades or new installations
Lead, mentor, and develop a multidisciplinary team of automation and process engineers, technicians, and system integrators
Define performance objectives, training needs, and career development plans for the team
Ensure the team, process, and systems align with applicable regulations
Own or support equipment/software validation protocols and risk assessments (e.g., FMEA)
Support internal and external audits (e.g., FDA, Notified Bodies)
Partner with R&D and Manufacturing Sciences to enable design-for-automation in new product development
Collaborate with QA, IT, and CSV teams to ensure systems are qualified, maintained, and detailed appropriately
Support tech transfer and scale-up activities by integrating automation into new or existing production lines
Manage cross-functional projects from initiation to completion

Skills

Key technologies and capabilities for this role

Automation StrategyRobotic Liquid HandlingSCADAIndustrial FillingPackaging AutomationPractical Process ImprovementEquipment Lifecycle ManagementProject ManagementURS GenerationVendor Selection

Questions & Answers

Common questions about this position

What are the key responsibilities of the Senior Manager Manufacturing Engineering role?

The role involves leading automation strategy, executing end-to-end automation projects, managing a multidisciplinary team, ensuring compliance with regulations like FDA and ISO 13485, and collaborating with R&D, QA, and IT teams.

Is this a remote position, or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What skills and experience are required for this role?

Candidates need technical leadership in automation platforms like robotic liquid handling and SCADA, expertise in project execution including CQV and FAT/SAT, knowledge of regulations such as FDA 21 CFR Part 820 and ISO 13485, and team leadership through Practical Process Improvement (PPI).

What does the company culture or work environment look like at Thermo Fisher Scientific?

The company emphasizes meaningful work with global impact, enabling career goals while tackling challenges like environmental protection and cancer cures, in an environment adhering to GMP safety standards, cleanrooms, and PPE requirements.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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