Production Engineer Sterile Processes

Meribel Pharma Karlskoga AB · Vollzeit

Box 410, Karlskoga, Schweden

Do you want to be part of developing the future of pharmaceutical manufacturing? We are seeking an engineer who wants to work with qualification, validation, and development of sterile processes and quality-critical production systems. This role suits you if you want to combine engineering, problem-solving, and regulatory requirements in an operation where quality and patient safety are central. About the Role As a Production Engineer specializing in sterile processes, you will be responsible for ensuring that our quality-critical equipment and processes meet the requirements of our operations, regulatory authorities, and customers. An important part of the role is to plan and conduct periodic revalidations of sterilization processes and to investigate deviations related to equipment and processes. You will work closely with production, the quality department, and other technical functions to ensure compliance with applicable regulations and continuous improvement of operations. Autoclaves and sterilization processes are an important specialty area, but the role also encompasses other types of production and process equipment. Key Responsibilities Be a technical specialist in sterile processes and sterilization Plan, conduct, evaluate, and document qualification and periodic revalidation of sterilization processes Investigate deviations, conduct root cause analyses, and drive CAPA activities Specify requirements, procure, and implement new production equipment Lead/Participate in investment and improvement projects Evaluate process data and identify improvement opportunities Provide technical support to the production organization What We're Looking For You hold an engineering degree in chemical engineering, biotechnology, mechanical engineering, or another relevant technical field You have experience from the pharmaceutical industry or other regulated operations You have knowledge of GMP or other quality-controlled working methods You are analytical, structured, and driven to solve complex technical problems Meritorious Experience with sterile processes, autoclaves, aseptic production, CIP/SIP systems, or qualification and validation within a GMP environment. What We Offer With us, you will have a unique opportunity to develop your specialist knowledge in a critical area of pharmaceutical manufacturing while working broadly with engineering, processes, equipment, and investments. You will be an important part of an experienced team with expertise in pharmaceutical manufacturing, automation, IT, investments, and process development. We work independently within our specialist areas but collaborate closely when solving complex technical challenges. The role spans from troubleshooting and qualification work to project management and implementation of new production equipment, which provides great variety in your day-to-day work and excellent opportunities for both personal and professional development. Welcome to become part of our team – where your expertise makes a difference! Meribel Pharma Solutions Meribel Pharma Solutions was founded in 2024 and is a niche, mid-sized CDMO specializing in providing customized pharmaceutical solutions to pharmaceutical companies. With headquarters in the United Kingdom and 11 facilities in Sweden, France, and Spain, we offer specialist expertise in sterile multi-dose, freeze-drying, sachets, and stick packages, as well as services to support development from concept to commercialization. We are dedicated to elevating pharmaceutical services to new heights and delivering comprehensive support through every step of a product's journey, whether the product is an oral solid dose, liquid, or semi-solid. Want to know more about us? Please visit our website: https://meribelpharma.com/. What We Offer You: With us, you will be an important part of a company on an exciting journey. Here you will work in an environment where improvement work truly makes a difference – both for the business and for your colleagues. A clean and structured GMP environment with stable processes. A team that values collaboration and development. A workplace where quality and safety are central, and where you have the opportunity to grow and make an impact. Favorable terms with collective agreement, ATK days, and wellness allowance and time off for all bank holidays. Sounds interesting to you? For questions about the position, contact: Stina Pernefur, Manager Production Engineering and IT mailto:[email protected] For questions about the recruitment process, contact: Sandra Lindell, HR Generalist mailto:[email protected] Application: Selection will be made on a rolling basis with final application deadline 2026-10-11. We look forward to receiving your application!