Sr. Validation Engineer at Thermo Fisher Scientific

Lengnau, Bern, Switzerland

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

  • Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field + 10 years experience or Master’s degree + 3 years in the engineering field, preferably in the pharmaceutical or chemical process industry
  • Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
  • Experience in the pharmaceutical industry for qualification & validation is required
  • Experience of multi-cultural work environment
  • Excellent verbal and written communication skills in English and preferably German or another European language
  • Strong understanding of GMP standards and regulatory requirements
  • Excellent technical writing skills with attention to detail
  • Proficiency in PC applications, including MS Office
  • Strong communication and interpersonal skills
  • Certification in technical writing or quality management
  • Experience with electronic documentation management systems (e.g., Documentum, TrackWise)

Responsibilities

  • Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales
  • Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions
  • Defines, in collaboration with other partners (Quality Assurance, System Owner…), the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activities
  • Coordinates execution of activities by external contractors
  • Performs requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and OMX following Good Documentation Practices
  • Participates in the culture of continuous improvement and development of technologies
  • Identifies training needs and develop training programs
  • Works in a safe and responsible manner in order to build an injury-free and incident-free workplace
  • Participates in calibration activities

Skills

Key technologies and capabilities for this role

GMPValidationRequalificationRevalidationQuality AssuranceGap AnalysisAudit ReportsGood Documentation PracticesCalibrationTraining ProgramsContinuous Improvement

Questions & Answers

Common questions about this position

What are the education and experience requirements for this Sr. Validation Engineer role?

A Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field plus 10 years experience is required, or a Master’s degree plus 3 years in the engineering field, preferably in the pharmaceutical or chemical process industry.

What key skills are needed for this position?

Candidates need functional knowledge of cGMPs and manufacturing operations in FDA regulated facilities, experience in pharmaceutical qualification and validation, excellent verbal and written communication skills in English (preferably German or another European language), strong understanding of GMP standards, excellent technical writing skills, and proficiency in MS Office.

Where is this job located and what is the work arrangement?

The role is based in Switzerland with standard office hours (40 hours per week). It involves working in office, cleanroom, and lab environments with PPE requirements and adherence to GMP safety standards.

What is the company culture like at Thermo Fisher Scientific?

The company values collaboration and innovation, is committed to making the world healthier, cleaner, and safer, and fosters a culture of continuous improvement, working safely to build an injury-free workplace, and participating in a great team.

What makes a strong candidate for this Sr. Validation Engineer position?

Strong candidates have experience in pharmaceutical qualification and validation, knowledge of cGMPs in FDA-regulated facilities, multi-cultural work experience, certification in technical writing or quality management, and familiarity with electronic documentation systems like Documentum or TrackWise.

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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