Senior Qualifying Specialist

vor 2 Wochen

Visp Valais, Schweiz Panda International Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

CQV Engineer | Life Sciences | Equipment & Facility Validation

Company Description

A leading pharmaceutical organization committed to ensuring compliance and quality within its engineering and manufacturing operations. The company focuses on maintaining the highest standards in equipment and facility validation, operating in alignment with cGMP and industry best practices. Employees are encouraged to collaborate across departments to drive efficiency, innovation, and quality improvements throughout the validation lifecycle.

Job Description

As a
Commissioning, Qualification, and Validation (CQV) Engineer
, you will be responsible for executing and managing activities related to equipment and facility validation. You will coordinate equipment installation, prepare and execute IQ/OQ/PQ protocols, and ensure documentation is completed in accordance with cGMP and internal quality procedures.

This role requires a strong understanding of validation principles, technical documentation, and regulatory requirements in a pharmaceutical manufacturing environment.

Key Responsibilities

  • Coordinate equipment installation and commissioning activities
  • Draft, execute, and document IQ/OQ/PQ protocols according to cGMP requirements
  • Prepare validation documentation, including URS, DQ, FMEA, FAT, SAT, and risk assessments
  • Write detailed validation reports for completed activities
  • Conduct GAP analyses and risk assessments to ensure compliance and identify improvements
  • Support validation lifecycle management, requalification, and maintenance programs
  • Contribute to continuous improvement of validation processes and procedures
  • Perform Quality Systems activities, including document control, change control, non-conformities, and CAPAs
  • Write and revise procedures related to engineering and validation activities
  • Ensure compliance with current regulatory standards and internal policies

Essential Requirements

  • Bachelor's degree in a Science or Technical field
  • Minimum of 5 years' experience in equipment or facility validation within the pharmaceutical industry
  • Strong technical writing skills and attention to documentation accuracy
  • Excellent organizational and time management abilities
  • Effective communication skills and ability to work collaboratively across departments
  • Fluency in
    Native
    German (mandatory)
    ;
    English proficiency
    is a strong advantage
  • Ability to work
    100% on-site

Additional Insights

Location:
Visp, Switzerland

Department:
Engineering / Validation

Contract Type:
Full-time, on-site

Language Requirements:
German mandatory; English a plus

Interested?
Please send your CV to
Miguel Gomes
at
m.-
or reach out directly at

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