Senior Process Validation

Om jobbet

Senior Process Validation

PharmaRelations is the Nordic market leader within consulting and recruitment services for the Life Science industry. We offer a professional yet down-to-earth business environment built on participation, trust, and short decision-making paths-where you will play an important role in our continued success.

Our driving force is to create value and development for our customers and consultants through high-quality consulting services, outsourcing solutions, and recruitment of specialists and leaders.

Today, we are more than 250 employees across the Nordic region, with offices in Sweden, Norway, Denmark, and Finland. Our headquarters is located in Frösundavik, Sweden.

We are now looking for a senior and highly skilled Senior Process Validation Consultant for a project-based assignment with immediate start

In this role, you will play a key part in ensuring that manufacturing processes meet regulatory and quality requirements. You will work hands-on with process validation activities, contributing to safe, efficient, and compliant API production. The assignment is carried out on site at the customer, and English is the working language.

Who Are We Looking For?

Main Responsibilities:

• Lead and execute process validation activities within API manufacturing

• Plan, perform, and document IQ, OQ, and PQ activities for manufacturing processes and equipment

• Support process design, process improvements, and technology transfers

• Perform and document risk assessments (e.g. FMEA, risk-based validation approaches)

• Ensure validation activities comply with GMP and regulatory requirements

• Investigate and manage deviations, changes, and CAPAs related to validation

• Collaborate closely with Production, QA, QC, Engineering, and other stakeholders

• Contribute to validation master plans, protocols, and reports

Required Qualifications:

• University degree (Bachelor's or Master's) in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related field

• Extensive experience in Process Validation within pharmaceutical or API manufacturing

• Proven hands-on experience with process validation, risk analysis, and lifecycle validation

• Strong knowledge of GMP and GxP regulations (EU GMP, ICH guidelines, FDA expectations)

• Experience working in regulated manufacturing environments, preferably API production

• Fluent English, both spoken and written (required). Finnish is a plus.

• Strong analytical skills, attention to detail, and the ability to work independently in a project-driven environment

• Confident communicator who can work cross-functionally and support stakeholders

Why PharmaRelations?

You will have the opportunity to work and grow together with a team of intelligent, innovative, and passionate experts across the Nordic region. PharmaRelations offers an environment where you are trusted, appreciated, and given the opportunity to make a real difference-not only for us, but indirectly for patients whose lives are improved and saved every day through the Life Science industry.

At the same time, PharmaRelations aims to become the best place to work within Life Science in the Nordics. We follow the Great Place to Work® model, and our definition of "the best" is to achieve top results compared to all Nordic Life Science companies. It is an ambitious goal, but one that drives us to continuously challenge ourselves and improve year after year.

What does the best place to work mean to you?

Apply Today!

Applications are reviewed on a rolling basis, so don't hesitate to apply. We look forward to hearing from you!

Please note that we cannot accept applications via email due to GDPR.