PEV Qualification Engineer

PEV Qualification Engineer

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

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.

Implement 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.

Teil V Stellvertreter / Part V Deputy

The employee is the deputy of the position PEV engineer and junior PEV for the following responsibilities

1. All the responsibilities of a PEV engineer and junior PEV engineer.

The employee is the deputy of the position CSV specialist for the following responsibilities.

1. Responsibilities similar to that of PEV engineer.

The deputy of the employee is PEV engineer or head of validation or CSV specialist for the following responsibilities.

1. All the responsibilities of a PEV engineer.

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!

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WuXi Biologics is an equal opportunities employer.