27 ago
|
Avertim
|
España
Your Role:
As a Medior Cleaning Validation Consultant, you will support validation and qualification activities within highly regulated GMP environments. You will collaborate with cross-functional teams and general stakeholders to define, execute, and maintain cleaning validation strategies, ensuring compliance with industry regulations and quality standards. Your expertise will contribute to the reliability and efficiency of manufacturing processes and cleaning systems for a leading client in the Life Sciences sector.
What will you do?
- Develop, review, and execute Cleaning Validation Master Plans, protocols, and reports
- Define cleaning validation strategies and acceptance criteria based on risk assessments and product characteristics
- Support cleaning process verification activities and ongoing monitoring programs
- Perform data analysis and assess cleaning validation results
- Investigate deviations, non-conformities, and out-of-specification results related to cleaning activities
- Ensure compliance with GMP requirements and applicable regulatory guidelines
- Collaborate with QA, Manufacturing, Engineering, Validation, and Technical Services teams
- Support inspections and audits by regulatory authorities and customers
- Participate in continuous improvement initiatives related to equipment cleaning and validation processes
- Provide technical expertise throughout the lifecycle of manufacturing and cleaning systems
Your Profile:
- Master’s degree in Engineering, Pharmacy, Biotechnology, Life Sciences, or a related scientific field
- Minimum 5 years of relevant industrial experience within the pharmaceutical and/or food industry
- Demonstrated experience in Cleaning Validation activities within regulated environments
- Strong knowledge of GMP standards and applicable regulatory requirements
- Experience with implementation, qualification, and validation of CIP (Clean-In-Place) and/or SIP (Sterilize-In-Place) systems
- Experience in risk assessment methodologies and validation lifecycle management
- Excellent analytical and problem-solving skills
- Strong communication and stakeholder management capabilities
- Ability to work autonomously while thriving in multidisciplinary project teams
- Professional proficiency in English and Dutch
About Avertim
We are a trusted partner for complex transformation programs. From strategy to operations, our consultants help clients perform, innovate, and comply, delivering sustainable change across Life Sciences & Chemicals, Banking & Insurance, Transport & Mobility, Energy & Utilities, and Telecom & Media.
What Avertim Offers
- High impact assignments with European clients in our core sectors
- A culture of experience, excellence, and diversity, working alongside subject-matter experts
- Learning & development tracks with mentoring, internal academies, and access to external trainings/certifications
- The opportunity to drive initiatives that perform, innovate, and comply with a sustainable mindset
- Salary package in line with your experience with extra-legal advantages (ex. company car, hospitalization insurance, bonus plan, meal vouchers, eco-cheques, and more)
📌 Medior cleaning validation consultant (España)
🏢 Avertim
📍 España