\\n Randstad (Schweiz) AG

We are currently seeking an experienced C&Q Engineer to join our dynamic Technical Services department. This critical role involves the management of Commissioning & Qualification activities, ensuring compliance with both global and local policies and legal requirements.

As a C&Q Engineer, you will report directly to the C&Q Manager, play an integral part in managing qualification phases, and contribute significantly to the successful execution of project timelines. If you possess a strong understanding of cGMP regulations, have excellent communication skills, and a proven track record in similar roles within the pharma industry, we would be delighted to hear from you.

We are keen to fill this position promptly, therefore we encourage you to apply at your earliest convenience.

Role and Responsibilities

As a C&Q Engineer, you will be responsible for a variety of tasks related to Commissioning & Qualification (C&Q) activities in our Technical Services department. Your duties will include, but are not limited to:

- Ensuring qualification phases are performed according to global and local company policies, legal requirements and regulatory authorities\\\' guidelines.
- Keeping Qualification Master plans up to date and established for all ongoing projects.
- Writing and reviewing Qualification plans, including DQ, IQ, OQ, PQ plans/protocols, and final reports for new or modified GMP utilities, facilities, and process / QC analytical equipment.
- Executing DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
- Coordinating and executing FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners.
- Overseeing and coordinating external suppliers.
Requirements

To be successful in this role, the following qualifications and skills are required:

- Bachelor/Master\\\'s degree in Engineering, technical or natural sciences.
- A minimum of 5 years of working experience within a pharma company in a C&Q/CQV equivalent position.
- Thorough knowledge of Qualification requirements according to cGMP regulations.
- Experience working with cross-department stakeholders.
- Understanding of quality assurance principles.
- Experience working in project teams and managing multiple projects in parallel.
- Knowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (ISO, ICH, FDA, ISPE).
Additionally, the following skills would be advantageous:

- Excellent communication skills.
- Analytical thinking and problem-solving ability.
- Business fluency in English. German language skills are a plus.
- Effective time management skills.Thank you for your application.
Contract

Branche: Anderes

Funktion: Anderes\\n \\n \\n \\n \\n \\n

\\n\\n Randstad\\n \\n\\n

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