Vacant job

Job Description

Are you a structured engineer driven by quality, precision, and independent work? Do you want to take the next step in your career and develop within the Life Science sector? Then this might be the right challenge for you!

As a consultant at Randstad, you will become part of a strong and cohesive team at our global client's site, while having Randstad's security and support behind you. In the role of Equipment Qualification Engineer, you will step into a responsible and dynamic environment where your primary focus will be to ensure that new equipment is qualified according to current regulations, as well as to drive and accelerate the work of closing identified gaps within Data Integrity (DI). You will play a key role in preparing the business for QC FDA audits, which requires a methodical approach and a sharp eye for detail. This position suits you if you thrive with a large degree of independent drive, but also value close and supportive collaboration with your colleagues to achieve common goals.

We are recruiting during the summer, but due to holidays, the process and our feedback may take slightly longer than usual. We handle applications on an ongoing basis and appreciate your patience during the holiday period.

Responsibilities

In the role of Equipment Qualification Engineer, you will work broadly with qualification and quality assurance. Your main tasks include:

• Drive and perform qualification of new equipment and associated systems (Equipment Qualification).
• Work actively with Data Integrity (DI) and support the accelerated work of closing existing DI gaps.
• Prepare and ensure that the QC business is ready for upcoming regulatory reviews, with a specific focus on QC FDA Audit Readiness.
• Write, review, and update qualification protocols, reports, and other relevant validation documentation.
• Collaborate cross-functionally with various departments to ensure that strict quality requirements and set timelines are adhered to.

Qualifications

We are looking for you who are an engaged and quality-conscious team player. To succeed in the role, we see that you meet the following requirements:

• Post-secondary education in biotechnology, chemistry, mechanical engineering, or other relevant engineering/scientific direction.
• Experience with equipment qualification (IQ/OQ/PQ) and validation within Life Science (GMP/GLP).
• Good knowledge of Data Integrity and understanding of regulatory requirements (e.g., FDA, ALCOA+).
• Experience in a QC environment and preparation for regulatory inspections (such as FDA audits) is highly desirable.
• Very good skills in Swedish and English, both spoken and written, as documentation and communication occur in both languages.

We place great emphasis on your personal suitability for this position. To thrive and succeed in the role, you are a methodical, structured, and meticulous person who always puts quality first. You have excellent collaboration skills and naturally take responsibility for the group delivering together according to set timelines and strict quality requirements.

Since the environment can change, you are flexible and communicative, with the ability and drive to independently move your work forward. We also see that you are curious, goal-oriented, and proactive, and that with your engagement you contribute to a positive and supportive work climate in the team.

About the Company

Randstad

At Randstad, we know that every person has a place on the labor market. With operations throughout the country and in all competence areas, we help people find a job that feels good, where they have the opportunity to grow, develop, and reach their full potential.

With nearly 600,000 employees in 38 countries, Randstad is the world leader in HR services, with the goal of becoming the world's premier and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.