Validation Engineer at Thermo Fisher Scientific

Auckland, Auckland, New Zealand

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor's degree in a scientific/engineering field or equivalent experience
Prior experience as a validation technician within a cGMP or analogous regulatory setting, particularly within the biopharmaceutical, pharmaceutical, or dairy sectors (desired)
Strong background in production process and/or manufacturing engineering
Technical knowledge in cGMP validation concepts and techniques
Highly self-directed, results-focused, and a great teammate with strong communication skills
Ability to work in manufacturing, laboratory, and office environments
Ability to stand for long periods while performing duties
Ability to work safely with chemicals, biologics, and hazardous materials
Ability to work overtime when required, with some 24-hour on-call duties
Occasional travel may be required
Adherence to Good Manufacturing Practices (GMP), safety standards, and use of PPE in environmental conditions including cold rooms/freezers (-22°F/-6°C), strong odors, and hazardous/toxic materials

Responsibilities

Show strong dedication and quick response to internal and external collaborators
Ensure outstanding conformance to quality systems, including ISO 9001 and cGMP
Develop, deliver, manage, and continuously improve the site master validation and metrology programs
Assist with engineering responsibilities, including maintenance and equipment selection
Communicate effectively with operational teams to resolve quality procedural and validation variances
Head and engage in quality advancement endeavors related to validations and engineering
Engage actively in audits conducted by customers and regulatory authorities
Carry out tasks in compliance with procedures to meet quality objectives
Contribute efficiently to quality advancement teams and foster teamwork between different departments
Develop procedures and protocols
Participate in Practical Process Improvement projects and problem-solving initiatives

Skills

cGMP

ISO 9001

Validation

Metrology

Calibration

GMP

Process Improvement

Equipment Maintenance

Auditing

PPE

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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