Qualification / Validation Compliance Engineer
Prismond Group SA
Zurich, Switzerland
vor 6 Tg.

Role & Responsibilities

The Qualification and Validation Compliance Engineer will support our Pharmaceutical client and conduct validation studies, technology transfer activities, process characterization studies and gauge R&R studies within the Manufacturing Process.

This position will also provide guidance on the equipment / process validation requirements and design control activities for new product development projects.

Support / conduct FAT / SAT and then IQ / OQ / PQ validation studies of equipment and processes, utilities and software validations

Advise project teams, develop / review and approve validation protocols and final reports

Manage Change Control on material specifications and documentation, develop and validate test method validation

Support of continuous improvement on process, and on Qualification and Validations project

Maintain equipment to support GMP manufacturing ensuring all equipment complies with Standard Operating Procedures and Policies

Participate in project planning, scheduling, and tracking

Develop and implement procedures to comply with corporate and industry standards

Provide internal and external trainings

Position Requirements

University degree in Engineering, Chemistry or another relevant discipline

At least 2-3 years of experience in Qualification and Validation activities and / or projects

Applied knowledge of SwissMedic and FDA and international Pharmaceutical regulations

Applied technical understanding of manufacturing equipment; processes specific to Pharmaceutical manufacturing preferred

Applied Knowledge of creation and verification of qualification equipment plans (FAT / SAT / DQ / IQ / OQ / PQ)

Analytical and structured working style; strong attention to detail

Ability to effectively work as part of a multidisciplinary, international team

Hands-on personality, with flexibility and dedication to maximize our client s value

Good verbal and written communication skills in English, German language is a plus

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