20 beste Stellen als process engineer in wuppertal – aktuell auf Personalsuche

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WuXi Biologics —Wuppertal
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PEV Qualification Engineer

WuXi Biologics -
Wuppertal

Jetzt bewerben

Details zur Stelle

Qualifikationen

SGU
Bachelor
Bioingenieurwesen

Vollständige Stellenbeschreibung

The PEV Qualification Engineer will be responsible for the management and implementation of qualification and validation activities at WTST, to ensure GMP compliance according to EU and FDA regulations, WuXi Biologics standards and WTST internal SOPs, including but not limited to, equipment/instrument/CTU commissioning/qualification/re-qualification, shipping validation, cleaning validation. Support the PEV department to maintain the qualification and validation status of the equipment and system. Implementing the quality event, such as QDV, deviation, change control, CAPA.

Department Description

As PEV Qualification Engineer, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the Head of PEV.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

Manage and coordinate commissioning, qualification, validation, re-qualification and periodic review activities.
Prepare qualification plans, protocols and reports, risk assessment and other CQV related documents.
Plan and execute equipment/system qualification, as well as sanitisation, cleaning, shipping validation in cooperation with system/process owners, contractors and suppliers.
Perform cycle development for various systems or process.
Support implementation of computerized system validation.
Lead risk assessment of equipment and systems.
Generate or revise SOPs for qualification and validation, based on internal and external regulations and standards.
Support CQV related troubleshooting.
Perform and support change control management, deviation management and CAPA management.
Track and manage open issues, such as punches, qualification deviations.
Follow ALCOA++ principals for any GMP documents.
Follow environmental health and safety guidelines set by the site and WuXi Biologics organization and perform activities as per risk assessments where required.
Receive and complete training in time.
Provide training or knowledge sharing to other team members.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

Bachelor of chemical engineering, biological engineering, pharmaceutical engineering or similar disciplines.
Minimum of 2 years of hands-on and management in C&Q, manufacturing, engineering in pharmaceutical/biopharmaceutical industry.

Besondere Kenntnisse / Special Knowledge

Knowledge in GXP regulatory requirements and industry standards related to biopharmaceutical industry, such as NMPA/EMA/PICs GMP, 21CFR Part 11/210/211, Annex 11and Annex 15 of EU GMP, GAMP 5, ICH Q9/Q10, ISPE Baseline Guidelines and PDA TRs.
Skilled in written and verbal English.
In-depth knowledge and experience in GMP, quality, EHS.
Strong collaboration, self-motivation, communication and influence.
Good knowledge on MC office application.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.com.WuXi Biologics is an equal opportunities employer.

Jetzt bewerben

Erweiterte Suche

process engineer Jobs in wuppertal

PEV Qualification Engineer

Supervisor Process Engineer (m/f/d) Contactor Manufacturing

Application Engineer

Demo & Exhibition Project Engineer (m/f/d)

Process Engineer- Separation Technology (m,f,d)

QA for ENG

R&D Data Management Reference Data Tech (all genders)

Field Applications Engineer

Sales Engineer - Southern Germany & Switzerland (m/f/d)

Team Lead Maintenance - Kobern-Gondorf near Koblenz / Mainz / Bonn

Project Manager for After Sales Services | EV Solutions

Time Scheduler / Work Preparation Engineer

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PMO Manager - Residential Flexibility Programme (f/m/d)

NCE Technology Expert - Mechanical Integrity (m/f/d)

Digital Solution Platform Architect (m/f/d)

Logistics Quality Specialist

Working Student Quality Assurance Charging Technologies

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