Looking for an exciting opportunity to lead a position at CCRM Nordic contributing to Sweden’s vision of becoming leader in Advanced Therapy Medicinal Products (ATMPs)?

Consider applying for the Validation Specialist role at CCRM Nordic.

About CCRM Nordic

CCRM Nordic is a newly established national infrastructure for commercialization of advanced therapy medicinal products (ATMPs). CCRM Nordic is a not-for-profit company based in GoCo Health Innovation City, Mölndal that aims to build process development and GMP ATMP manufacturing capabilities during the coming years. CCRM Nordic vision is to benefit patients by enabling commercialization of advanced therapies.

Position

Validation Specialist

CCRM Nordic office at GoCo Health Innovation City Mölndal Gothenburg, Sweden

Full time, 100%

About the role

We are looking for a thorough, communicative, and driven Validation Specialist to support our Quality Department.

As a Validation Specialist you are responsible for developing and executing processes related to validation and qualification, defining User Requirement Specifications (URS) performing risk analysis, writing and/or executing test and validation plans, and evaluating test and validation outcome and coverage.

As the Validation Specialist, you’ll conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business.

This role will be based in our offices at GoCo Health Innovation City and reports to our QA Manager.

Main tasks and responsibilities:

The work is performed in cross-functional teams that include QA/QC, Process development, Manufacturing, and external suppliers in a highly collaborative, competent, and engaged environment.

• Develop validation strategies, documentation and improving process validation methods/SOPs in compliance with CCRM Nordic’s quality management system built on regulatory requirements from the European GMP ATMP directive.
• Participate in the development or modification of validation packages, develop user requirements specifications, design plans, and risk management deliverables (e.g., FMEAs).
• Execute, and evaluate tests and validation outcome and coverage.
• Conclude and report the outcome of qualification and validation. Summarize test results and determine whether a process meets its’ acceptance criteria.
• Assist in developing and maintaining up-to-date documentation for software validation and implementation.
• Maintain awareness of standards that regulate our industry and ensure compliant documentation, conducting tasks related to area of responsibility with management oversight.
• May lead projects with a limited scope, but usually a contributor on broader projects.
• Risk Management - Apply basic Risk Management principles to work.

Qualifications/Skills:

• An academic background (M. Sc./B. Sc.) within relevant area.
• 3-5 years of experience working with qualification and validation within the Life science industry.
• Understanding of the V-model (DQ/IQ/OQ/PQ) for process validation and the interpretation of ISO/GMP standards
• Experience in Quality Management Systems /Production/Product/Process Development, preferably within the life science industry
• Experience working with technical specifications and external suppliers.
• Professional proficiency in English is a must, any Swedish proficiency is a benefit.

Ideal Candidate, also

• Bachelor’s degree or higher in Computer science or corresponding experience in Software/Computerized systems and validation.
• 3-years of experience working with IT compliance/Computerized systems and validation.
• Knowledge within quality assurance and relevant regulations and guidelines e.g. Eudralex Vol.4 EU GMP Annex 11, Annex 15, GMP for ATMP, GAMP5, FDA 21 CFR Part 11
• Has a pragmatic and solution-oriented approach to new challenges.
• Has good communication skills and shares knowledge and supports colleagues.

Why work at CCRM Nordic

This is an opportunity to make a real impact in the field, shaping the direction of regenerative medicine in the Nordics together with a dedicated enthusiastic team.

You should be based around the Gothenburg region and able to attend our Mölndal office on a regular basis.

Application

Please submit your application as soon as possible to [email protected] as interviews will be held continuously as strong applicants are identified. Please label your application with “Validation Specialist”.