PEV Qualification Engineer

Overview

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.

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++ principles for 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.
• The employee is the deputy of the position PEV engineer and junior PEV engineer for the following responsibilities.

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.
• Knowledge in GXP regulatory requirements and industry standards related to biopharmaceutical industry, such as NMPA/EMA/PICs GMP, 21CFR Part 11/210/211, Annex 11 and 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.

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

• 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.

• All the responsibilities of a PEV engineer.

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Would you like to know more before you apply? Please visit us at WuXi Biologics is an equal opportunities employer.