Vacant job

Job Description

Are you a structured and driven Process Engineer with experience in GMP and deviation management? Are you looking for an exciting consultancy assignment where you can make a real difference in sterile pharmaceutical production? Then this role might be for you!

About the Role

As a Process Engineer, your focus will be on Late Deviation Closure within the production of Bulk, Drug Substance (DS), and filling. You will work in a regulated environment where your primary responsibility will be to investigate complex deviations, identify root causes (Root Cause Analysis), and ensure that appropriate CAPA measures (Corrective and Preventive Actions) are implemented.

This position is a consultancy assignment through Randstad. Working as a consultant at Randstad offers a fantastic opportunity to broaden your network, gain valuable experience, and develop your career. With us, you get a secure employment with collective agreements, market-competitive salary, wellness allowance, and above all, a dedicated consultant manager who supports you in your professional development. You will become part of a strong team at our client's site, while having Randstad's security in your back.

Responsibilities

• Drive, investigate, and close late deviations (Late Deviation Closure) within Bulk, DS, and filling production.
• Conduct thorough root cause analyses in accordance with GMP guidelines.
• Formulate, implement, and follow up on effective CAPA measures.
• Work in quality systems, preferably TrackWise, for documentation and case management.
• Collaborate with cross-functional teams to ensure timelines and quality requirements are met.

Qualifications

To thrive and succeed in this role, we see you as a careful team player who is motivated by structure, but who also has that natural drive to want to do things a little better tomorrow than they were done yesterday.

We are looking for someone who has:

• Education: Academic degree (PhD/MSc/BSc) in Chemistry, Biotechnology, or equivalent.
• Experience: Previous experience in the pharmaceutical industry (Pharma) with a focus on aseptic/sterile production and GMP.
• Competence: Documented experience in deviation management (Deviation and CAPA management) as well as root cause analysis.
• Systems: Experience working in TrackWise is highly advantageous.
• Languages: Fluent in both Swedish and English, both verbally and in writing.

Your Profile

We place great emphasis on personal suitability for this position. As a person, you should be flexible, careful, have good communication skills, and be curious, goal-oriented, and structured. It is important that you have excellent teamwork skills and take responsibility so that the group delivers according to set timelines and quality requirements. Furthermore, we would like you to be methodical, proactive, and contribute to a positive work climate.

About the Company

Randstad

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

With nearly 600,000 employees in 38 countries, Randstad is a 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.