Job Title: Validation Engineer - Quality Assurance Specialist
We are seeking a skilled Validation Engineer to support the quality assurance and compliance of our pharmaceutical manufacturing processes. As a key member of our team, you will play a vital role in ensuring the accuracy and reliability of our equipment, systems, and processes.
Main Responsibilities:
* Design, execute, and report on Process Performance Qualifications (PPQ) for new products, equipment, and processes.
* Conduct validation studies for equipment, systems, and processes to ensure compliance with regulatory requirements.
* Provide technical guidance on FDA and EU validation requirements for aseptic processing, sterilization, depyrogenation, and lyophilization.
* Maintain validation documentation throughout the product lifecycle and ensure equipment and systems remain compliant.
* Support site change control processes and participate in regulatory inspections.
Requirements:
* 3-5 years' experience in a healthcare manufacturing environment (pharmaceutical experience preferred).
* Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).
* Strong technical knowledge of pharmaceutical plants, validation, and process development.
* Familiarity with cGMP, GAMP, ISPE, FDA/EU guidelines, and validation standards (AAMI/ANSI, PDA, ISO).
* Excellent problem-solving skills and the ability to troubleshoot validation challenges.
* Proficiency with MS Project, SPC packages, and an understanding of site KPIs is a plus.
Benefits:
* Opportunity to work with a leading pharmaceutical company.
* Collaborative and dynamic work environment.
* Professional growth and development opportunities.