Validation (CQV)

Job Description: Commissioning and Qualification Engineer (4-month Contract)

Position: Commissioning and Qualification Engineer

Location: Janssen Bern, Switzerland

Duration: 4-month Contract for a CAPEX project

Overview:

We are seeking 2 highly skilled Commissioning and Qualification Engineers for a 4-month contract position to support a capital expenditure (CAPEX) project at Janssen Bern. As a Commissioning and Qualification Engineer, you will play a crucial role in ensuring the successful commissioning and qualification of facilities, systems, and equipment in compliance with applicable regulations and industry standards.

Responsibilities:

- Support the overall commissioning and qualification activities for the 4-month CAPEX project at Janssen Bern.

- Collaborate with project stakeholders to develop commissioning and qualification plans, protocols, and reports.

- Execute commissioning activities, including system turnover verification, alignment checks, functional testing, and documentation of results.

- Perform qualification activities, including installation and operational qualifications (IQ/OQ).

- Work closely with cross-functional teams to coordinate and integrate commissioning and qualification activities within project timelines.

- Identify and mitigate risks during the commissioning and qualification phase, ensuring compliance with regulatory requirements and safety standards.

- Utilize industry best practices and standard operating procedures to conduct commissioning and qualification activities.

- Collaborate with project team members to ensure documentation is completed accurately and on schedule.

Requirements:

- Bachelor's or Master's degree in Engineering or a related field.

- Minimum of 5 years of experience in commissioning and qualification activities in in pharmaceuticals or biotechnology industry.

- Strong knowledge and understanding of GMP (Good Manufacturing Practice) guidelines and regulatory requirements.

- Experience in developing and executing commissioning and qualification plans, protocols, and methodologies.

- Proficient in conducting system turnover verification, functional testing, and documentation of results.

- Familiarity with qualification activities such as IQ/OQ.

- Excellent problem-solving and analytical skills, with the ability to identify and resolve issues proactively.

- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

- Detail-oriented, with exceptional organizational skills and the ability to manage multiple tasks and priorities simultaneously.

- Availability to commit to a 4-month contract duration.

- Business fluency in English, German language is a plus

Kontakt: Alba Jansa + 41 61 282 22 13