Validation Support
The position
A Validation Assistant in the pharmaceutical industry plays a critical role in ensuring that all systems, processes, and equipment meet regulatory and quality standards.This role is essential for maintaining compliance and ensuring the reliability and efficiency of pharmaceutical operations
Responsibilities
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
- Analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
- Ensure compliance with regulatory requirements and industry standards.
- Prepare comprehensive validation reports and documentation.
- Coordinate with cross-functional teams, including quality assurance, engineering, and production.
- Perform risk assessments and develop mitigation strategies related to validation activities.
- Review and approve validation deliverables from vendors and third-party service providers
- Support the preparation and execution of Aseptic Process Simulation
Requirements
- Bachelor's degree in a relevant field, such as engineering or life sciences.
- Experience (3-4 years) in validation within a regulated industry, preferably pharmaceuticals.
- Strong understanding of validation protocols and regulatory requirements.
- Excellent analytical and problem-solving skills.
- Attention to detail and strong organizational skills.
- Ability to work collaboratively with cross-functional teams.
- Proficiency in technical writing and documentation.
- Knowledge of industry standards, such as GMP, PICs, or ISO
Skills
- Validation Protocols: Developing and executing IQ, OQ, PQ protocols.
- Regulatory Knowledge: Understanding of GMP, PICs, and ISO standards.
- Analytical Thinking: Ability to analyze data and identify trends.
- Technical Writing: Proficiency in preparing detailed validation reports.
- Problem-Solving: Ability to troubleshoot and resolve validation issues
What we offer:
- For this position we offer a permanent contract
- Free access to the company canteen or ticket restaurants;
- A range of benefits for you physical, financial, social and mental wellbeing (access to gyms, physiotherapist, psychologist, volunteering, parental support, company welfare and more);
- A support to develop your own professional and personal path that will guide you through our full range of development programs including platforms to learn foreign languages and attend professional courses.
In Boehringer Ingelheim we are committed to guarantee equal opportunities; we believe in respect, trust and empathy, in a work environment without discrimination.
We are powered by our people as we know that our differences are our strengths. We value everyone and each of us feels included, important and at ease.
This job requisition is addressed also for candidates with disabilities and belonging to protect categories following articles 1 and 18, Law 68/99.