Validation Lead

Om jobbet

Do you want to take full ownership of validation strategies in a manufacturing-focused CDMO environment - and lead validation activities related to new product introductions and tech transfers?

Meribel Pharma Solutions

Employment type: permanent fulltime-position with daytime working hours and flexible scheduling

Location: You are based in the Skåne region and able to commute to the Höganäs site on a daily basis

Meribel Pharma Solutions is again partnering with PharmaRelations and we are now looking for a Validation Lead/ senior Validation Engineer with strong expertise in process and product validation to join the site in Höganäs, combining a coordinating, project-leading role with a hands-on approach when required.

About the role - a senior and strategic validation position

In this role, you will join Meribel as a Validation Lead, with overall responsibility for driving validation strategy, planning and execution across a range of activities. The role has been redefined to reflect increased seniority with focus on both hand-on execution and strategic ownership of validation.

You will act as a project lead in both customer and internal projects, working closely with production, quality and technical specialists. This is an independent specialist role at site level, requiring strong autonomy, prioritisation skills and cross-functional collaboration.

The position is based at the Höganäs site and requires a high level of on-site presence to enable close collaboration with production staff and technicians, and to manage validation during production windows. Commuting from nearby locations (e.g. Helsingborg) is possible, but site presence is key.

Manufacturing environment (Höganäs)

The Höganäs site operates large-scale manufacturing. Core processes include powder blending, granulation and filling into sachets, making essential solid understanding of manufacturing processes and product quality.

Validation activities often take place during ongoing production in defined time windows, requiring strong planning skills, clear communication and close collaboration with operators and technicians.

Key responsibilities

Your responsibilities will include, but are not limited to:

• Developing and driving validation strategies, as well as planning, leading and following up validation activities in cross-functional teams.
• Leading and performing process and product validation, particularly related to new product introductions and tech transfer (highly meritorious).
• Preparing validation documentation such as validation plans, protocols and reports and documenting and evaluating validation results.
• Managing deviations and improvement actions within validation assignments.
• Contributing to the development and continuous improvement of validation processes and documentation, in close collaboration with the site Quality function.
• Developing and executing the annual plan for periodic review, ensuring qualified status of GMP-classified systems and processes.
• Leading and participating in both customer-related and internal projects.

Who we are looking for

We are looking for a candidate who has:

• 5-10 years of experience in product validation within the pharmaceutical industry.
• Strong expertise in process and product validation (core focus of the role).
• The ability to structure, lead and coordinate work in a cross-functional manufacturing environment.
• Experience of applying a risk-based approach to validation activities.
• Solid understanding of manufacturing processes, including how process parameters impact product quality, with experience of solid dosage forms.
• An engineering degree in chemistry, biotechnology or a related field.
• Fluency in both Swedish and English, written and spoken (Swedish is a mandatory requirement due to documentation and shop-floor interaction).

As a person, you are analytical, hands-on and solution-oriented, with a structured way of working. You are comfortable coordinating activities across functions, taking a project-lead role when needed, and working close to operations. You communicate clearly, collaborate effectively with multiple stakeholders, and are able to balance attention to detail with a holistic perspective.

Meritorious experience

• Experience in Tech Transfer and leading validation during product transfers between sites

• Experience in Cleaning Validation (CV) is considered meritorious, but not a core requirement for the role

• Experience in project management and/or LEAN

• Experience in CSV is beneficial but not required; support is available internally and via external partners

About Meribel Pharma Solutions

Meribel Pharma Solutions Founded in 2024 is a niche, mid-sized CDMO specialising in providing tailored pharmaceutical solutions to pharmaceutical companies. Headquartered in the UK and with 11 facilities in France, Spain and Sweden, Meribel offers specialist expertise in sterile multidose products, lyophilisation, sachets and stick packs, as well as services to support development of products from concept to commercialisation.

Meribel Höganäs site is specialised in the manufacture and packaging of granulated and powder-based pharmaceutical products, with a strong focus on sachets and stick filling, as well as packaging technologies such as primary and secondary packaging, serialisation and aggregation.

Why Meribel?

At Meribel, you will join an established manufacturing site with a clear improvement focus and the opportunity to shape validation structures and ways of working. We value respect, trust and transparency, and seek colleagues who share these values.

The Recruitment Process - Your Application

PharmaRelations is managing the targeted search on behalf of Meribel Pharma Solutions. If you believe your background and expertise align with the requirements, we encourage you to submit your application through the "Apply" button. We will review all applications with great care in our search for the right candidate. A kind reminder is that the application documents should not be sent via email. For questions regarding the position, you are welcome to contact Kristina Edholm ( kristina.edholm@pharmarelations.se ) or Maximiliam Haffen Lamm ( maximilian.lamm@pharmarelations.se ).