Validation Engineer II, GMP at Thermo Fisher Scientific

Tilburg, North Brabant, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Proven hands-on experience in Commissioning & Qualification and Validation in a highly regulated pharmaceutical environment or equivalent
Expertise in crafting new equipment, changing processes, growing production, and implementing new products
Bachelor's degree or equivalent experience in technology, science, or related field (preferred)
Prior experience in validation, GMP, or pharmaceutical manufacturing
Personal characteristics: Integrity, Intensity, Innovation, and Involvement
Willingness to learn

Responsibilities

Co-draft User Requirement Specifications (URS) with suppliers and multi-disciplinary team
Draft validation plans and implement protocols for C&Q/IQ/OQ/PQ related to equipment, utilities, processes, cleaning, and computer validation, including final reports and advice on periodical review frequencies
Extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes, including Continued Process Verification (CPV)
Provide validation technical support to other departments
Draft, review, and amend procedures, Validation Master Plan, and other validation audited documents
Ensure validated status of all cGMP-critical automated process applications and quality systems
Stay abreast of current developments and regulations in the pharmaceutical industry
Act as validation SME for internal and external audits

Skills

Key technologies and capabilities for this role

GMPCommissioning & QualificationIQ/OQ/PQURSValidation ProtocolsCleaning ValidationComputer ValidationCPVPeriodic Review ReportscGMP

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Validation Engineer II role?

Candidates need proven hands-on experience in Commissioning & Qualification and Validation in a highly regulated pharmaceutical environment, with prior experience in validation, GMP, or pharmaceutical manufacturing required. Preference is given to those with a bachelor's degree or equivalent in technology, science, or a related field, plus a willingness to learn.

What are the core personal characteristics expected for this position?

The role expects candidates to embody Integrity, Intensity, Innovation, and Involvement, while enjoying leading change and working in a matrix organization to improve processes.

Is this a remote position, or does it require office work?

This is an office-based role with standard Monday-Friday hours in Tilburg.

What does a typical day involve for the Validation Engineer II?

Responsibilities include drafting User Requirement Specifications, validation plans, and protocols for C&Q/IQ/OQ/PQ; generating Periodic Review Reports; providing technical support; and acting as a validation SME for audits.

What makes a strong candidate for this Validation Engineer II position?

Strong candidates have hands-on validation experience in pharma/GMP, expertise in equipment qualification and process changes, and align with values like Integrity, Intensity, Innovation, and Involvement, with a passion for leading change in a matrix team.

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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