Thermo Fisher Scientific

Technical Documentation & Compliance

Lengnau, Bern, Switzerland

Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Biotechnology, Quality AssuranceIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific or technical field, such as Life Sciences, Engineering, or Technical Writing, and a minimum of 2-3 years of experience in technical writing, deviation management, or change control, preferably within the pharmaceutical or biotechnology industry. Strong understanding of GMP standards and regulatory requirements is essential, along with experience documenting deviations and managing change control processes.

Responsibilities

This role involves documenting deviations, including root cause analysis, corrective actions, and preventive measures; drafting and managing change control records to ensure changes align with GMP standards; producing clear and concise technical documents such as SOPs, work instructions, and reports; collaborating with production, quality, and engineering teams to gather information and ensure accurate documentation; supporting continuous improvement initiatives; training and guiding staff on deviation and change control procedures; supporting audits by providing documentation and resolving findings related to deviations and change management; adhering to general cGMP rules, Quality policies, procedures and instruction; and actively contributing to safety initiatives and issues, as well as near miss reporting and follow-up.

Skills

GMP
Deviation Management
Change Control
SOPs
Work Instructions
Root Cause Analysis
Corrective Actions
Preventive Measures
cGMP
Technical Writing
Regulatory Requirements
Auditing

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.

Key Metrics

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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