4 beste Stellen als it support in biel bienne be – aktuell auf Personalsuche

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Senior CQV Engineer

Thermo Fisher Scientific -
Lengnau, BE

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 13 Stunden

Qualifikationen

Management-Erfahrung
Biotechnologie
Englisch
Microsoft Office
Master
Bachelor
Produktion
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join Thermo Fisher Scientific Inc. as a Sr CQV Engineer and become part of a great team in Switzerland! This is an outstanding opportunity to work with a world-class company committed to making the world healthier, cleaner, and safer. We value collaboration and innovation, and we are excited to welcome an experienced individual who shares our dedication to excellence.

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

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)

If you are driven and excited to support our mission, we would love to hear from you. Apply today and take the next step in your career with Thermo Fisher Scientific Inc.!

Jetzt bewerben

Erweiterte Suche

it support Jobs in biel bienne be

Senior CQV Engineer

Sachbearbeiter:in HR Administration

Postdoctoral Position in Neuronal Current Imaging and EEG-fMRI

SAP SD Modulberater/-in Professional (1069)

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Ich möchte aktuelle Job-E-Mails für Stellen als it support in biel bienne be erhalten

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