Process Engineer at Thermo Fisher Scientific

Allentown, Pennsylvania, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, ManufacturingIndustries

Requirements

At least 3 years of engineering experience in a relevant cGMP controlled environment (5-10 years highly desirable), preferably in pharmaceutical or food industry
Bachelor of Science degree from an accredited college or university in Packaging, Electrical, Mechanical, Industrial Engineering, or related field
Proficiency in pharmaceutical or food packaging operations; experience with automated packaging, labeling, bottling, or device assembly equipment preferred
Strong foundation in Lean, Six Sigma, SMED, and structured problem-solving methodologies
Mechanical proficiency with proven experience resolving issues with packaging equipment
Proficient in authoring equipment onboarding and qualification documentation (URS, FDS, FMEAs, FAT/SAT/Commissioning protocols, SOPs, Work Instructions)
Strong written and verbal communication skills to explain technical information to non-technical collaborators, including clients
Proficiency with MS Office, especially Excel, for data analysis and project tracking
Ability to support and advance multiple priorities in a fast-paced, multi-functional environment
Ability to occasionally lift up to 10 lbs. and perform activities such as bending, reaching, and standing
Adherence to GMP standards, site safety practices, Cleanroom requirements (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair), and PPE usage (safety glasses, gowning, gloves, lab coat, ear plugs)

Responsibilities

Ensure full compliance with GMP standards, site safety practices, and company values (Integrity, Intensity, Innovation, Involvement)
Assist in ongoing improvement efforts to cut costs, boost efficiency, enhance product quality, and streamline workflow
Lead technology transfer activities for new and existing client products, including documentation, qualification, and alignment to project timelines
Drive capital expenditure (CAPEX) projects from initiation through equipment installation and operational integration
Develop equipment specifications and user requirements (URS or equivalent), lead vendor evaluations, drive design reviews, and perform FAT/SAT, commissioning, and validation activities
Onboard and integrate new equipment, automation platforms, and production technologies to improve throughput, reduce manual operations, and enhance control
Collaborate with Production and Operations to identify and resolve workflow bottlenecks and performance constraints across packaging lines
Support in resolving complex issues on packaging equipment, working with maintenance, OEMs, and operators to identify root causes and implement sustainable solutions
Conduct deviation investigations, CAPAs, and change control management
Review, develop, and approve Engineering and Validation documents, including protocols, specifications, and SOPs
Perform additional duties as needed to meet business and operational objectives

Skills

Key technologies and capabilities for this role

GMPcGMPProcess EngineeringTechnology TransferCAPEX ProjectsEquipment ValidationFATSATCommissioningAutomationCleanroomPPE

Questions & Answers

Common questions about this position

What experience level is required for the Process Engineer role?

Applicants should possess at least 3 years of engineering experience in a relevant cGMP controlled environment, with 5-10 years highly desirable.

What education is required for this position?

A four-year Bachelor of Science degree from an accredited college or university in Packaging, Electrical, Mechanical, or Industrial Engineering or a related field is required.

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

This is an on-site full-time position in a GMP-regulated pharmaceutical packaging environment requiring adherence to cleanroom standards and PPE.

What are the company's core values?

The company values Integrity, Intensity, Innovation, and Involvement.

What makes a strong candidate for this Process Engineer role?

Strong candidates have 5-10 years of experience in pharmaceutical or food packaging operations in a cGMP environment, proficiency with automation, and expertise in leading CAPEX projects, technology transfers, and validation activities.

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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