Staff Validation Engineer (West Hills, CA) at Thermo Fisher Scientific

West Hills, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, BiotechnologyIndustries

Requirements

Bachelor’s or Master’s Degree in Chemistry, Biology, Engineering or equivalent
Minimum of 5 years experience in validations, Quality assurance (QA), or engineering within a GMP environment
Proven validation experience in the medical device (ISO 13485), bio-pharmaceutical, or related industry
Experience with developing process improvements for validations of equipment, processes and production lines
Legally authorized to work in the United States without sponsorship
Ability to pass a comprehensive background check, including a drug screening
Ability to adapt to rapid changes in project priorities and meet challenging deadlines

Responsibilities

Oversee continuous improvements in validation processes to improve efficiency and quality
Lead the preparation and execution of validation documentation, including User Requirements Specifications, Installation and Operational Qualification Protocols and Reports, Performance Qualification Protocols and Reports, and Validation Protocols and Reports
Cover validation of equipment, computer systems validation, and process validation, working closely with the site to produce a complete validation package
Provide guidance and mentorship to system owners with impact risk assessments to identify qualification and validation requirements
Carry out validation activities on equipment and processes before returning or handing over to the system owner
Assist in arranging external services when required
Train and advise staff on validation guidelines
Lead multi-functional teams including operations, external contractors, and internal multi-functional teams to complete validation protocols and reports
Maintain all documentation (electronic and hardcopy) in line with the quality management system
Ensure compliance with safety, health, and environment (OSHA) legislation
Develop a compliant and efficient validation strategy for equipment (IOPQs) and process validations for temperature-controlled storage, diagnostic instruments, and production lines
Connect and communicate with all individuals across the business, relaying information about benchmarks and ongoing projects

Skills

Validation Protocols

User Requirements Specifications

IQ/OQ/PQ

Computer Systems Validation

Process Validation

Equipment Validation

Risk Assessments

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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