Manufacturing Process Engineer II at Thermo Fisher Scientific

Logan, Utah, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, ManufacturingIndustries

Requirements

Bachelor's of Science (preferably in Mechanical, Electrical or Industrial Engineering)
2 years of process engineering experience
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Compliance with Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc
Ability to work in Office and Cleanroom environments
Use of some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Outstanding attention to detail and organizational skills to handle time and prioritize tasks
Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships
Experience with Data Integrity principles for automation systems and audit trail data (a plus)

Responsibilities

Provides technical support and expertise to sterile pharmaceutical production and modifications to existing processes and auxiliary support systems
Leads process improvements to increase safety, reduce costs, improve quality and improve Overall Equipment Effectiveness (OEE)
Minimizes production equipment downtime to increase equipment availability and efficiency along with regulatory compliance for process and support systems
Works closely with Production, Maintenance, Validation and Quality to maintain cGMP compliance, injury-free workplace, and on-time product delivery
Encourages a collaborative team spirit, encouraging a productive and supportive work atmosphere, implementing critical initiatives, and improving the team's skills to boost OEE and achieve business unit goals
Diagnoses and resolves difficult process and equipment interactions to maintain system readiness, collaborating with other teams and communicating resolution summary to Area Leadership
Develops process flow diagrams, problem solving guides, authors Standard Operations Procedures (SOP) and Job Aids to increase process efficiencies and repeatability
Creates and leads all aspects of alignment to User Requirement Specifications (URS), Functional Specifications, Design Specifications, and related user documentation to achieve and define process functionality and compliance
Establishes technical fit into existing facilities and equipment layouts, identifies process requirements, recognizes efficiency and safety gaps and drives technical solutions
Provides supporting data on process systems and equipment to production and quality investigations along with proposing solutions and improvement opportunities
Collaborates with Validation, Engineering and Customer teams to ensure process consistency during routine operations and modifications to processes maintain GMP standards (FAT, SAT, IQ/OQ/PQ)
Documents conditions, actions, and results of work performed following company policies and procedures in logbooks and shift reports
Owns results by taking actions to correct deficiencies and reports variances and exceptions in processes
Drives Continuous Improvements using metrics, TPM, 5S, and the PPI process

Skills

Key technologies and capabilities for this role

GMPcGMPOEEProcess ImprovementSterile ManufacturingCleanroomPPEValidationQuality AssuranceEquipment Maintenance

Questions & Answers

Common questions about this position

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

This role is performed on-site at the Logan, Utah location and involves working in cleanroom and office environments with PPE requirements.

What are the key responsibilities of this Manufacturing Process Engineer II role?

The role involves providing technical support to sterile pharmaceutical production, leading process improvements for safety, cost reduction, quality, and OEE, diagnosing equipment issues, developing process documentation, and collaborating with Production, Maintenance, Validation, and Quality teams.

What skills or experience are required for this position?

Candidates need expertise in process improvements, diagnosing equipment interactions, developing SOPs and process flow diagrams, aligning to URS and specifications, and ensuring cGMP compliance, with the ability to lift 40 lbs. and adhere to cleanroom standards.

What is the work environment and culture like at Thermo Fisher Scientific for this role?

The role emphasizes a collaborative team spirit, productive and supportive work atmosphere, working closely with Production, Maintenance, Validation, and Quality teams in a cGMP-compliant, injury-free workplace with cleanroom and PPE requirements.

What makes a strong candidate for this Manufacturing Process Engineer II position?

Strong candidates will have experience leading process improvements, technical expertise in pharmaceutical production systems, collaboration skills across teams, and the ability to drive OEE enhancements while ensuring regulatory compliance.

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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