Senior Validation Engineer at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Life Sciences, ManufacturingIndustries

Requirements

Bachelor’s degree in Science, Engineering, or Statistics, or meaningful work experience
Preferably 5 years of confirmed Biotech experience in commercial-scale manufacturing operations
Strong communication and interpersonal skills
Good presentation, planning, and organizational skills
Confirmed leadership and mentorship abilities
IT foresight and adaptability
Ability to collaborate with complementary teams
Demonstrated dedication to continuous improvement and customer focus
Ability to balance multiple projects and tasks simultaneously while meeting agreed due dates
Strong attention to detail and dedication to quality orientation principles

Responsibilities

Assist Validation Department for commissioning and qualification of Equipment, Facilities and Utilities, in compliance with pertinent regulations (e.g., TGA, FDA, EMA)
Coordinate tracking of validation protocol execution status and ensure completion of validation projects per required schedules
Prepare, execute and/or review validation documentation, including but not limited to FDS, DQ, IOQ, PQ, CSV etc
Track and resolve anomalies during qualification activities
Develop project plans for validation processes
Provide validation support and associated mentorship for equipment, facility and utilities qualification processes
Represent validation at external and internal audits
Perform validation activities and achieve assigned targets, standards and/or departmental goals
Manage priorities in the planning of actions and resources, and strategic goals set for the department in line with company goals and yearly plans
Achieve cost consciousness within the department
Be a role model for Validation systems and policies for Brisbane site
Supervise external technological, legal and regulatory developments around Validation and assess their applicability to and consequences for Brisbane site
Harmonise with validation teams in other BIO sites to identify and implement standard methodologies
Drive continuous improvement in costs and results within validation activities
Ensure EH&S in Validation activities
Assist validation contractors to meet current and future requirements in terms of quality and quantity to establish and maintain cGMP compliance
Lead and supervise the execution of all relevant validation activities within the Manufacturing and Laboratory areas, integrating their timeline with ongoing projects and programs
Maintain a safe and balanced working environment
Champion the awareness for EH&S and Quality within department

Skills

Validation

Equipment Qualification

Facilities Qualification

Utilities Qualification

IOQ

CSV

FDS

Validation Protocols

Regulatory Compliance

FDA

EMA

TGA

SOPs

Audit Representation

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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