**Job Title:** Senior Validation Engineer
**About the Role:
* We are seeking an experienced Senior Validation Engineer to join our team. The successful candidate will lead and support quality control for equipment qualification, oversee IQ, OQ, PQ activities and documentation, mentor junior staff, and promote best practices.
* The ideal candidate will have a strong understanding of regulatory and industry best practices, excellent leadership and communication skills, and experience with aseptic fill/finish, OSD, gene therapy, or biotech processes.
Key Responsibilities:
* Lead and support quality control for equipment qualification
* Oversee IQ, OQ, PQ activities and documentation
* Mentor junior staff and promote best practices
* Review and complete validation protocols (TOPs, QSRs)
* Ensure proper planning of materials and consumables
* Maintain documentation quality and regulatory compliance
* Coordinate with vendors and contractors to ensure standards are met
* Participate in FAT, SAT, and other qualification phases
* Drive continuous improvement in validation procedures
Requirements:
* Bachelor's or Master's degree in Science, Engineering, or related field
* Minimum 5 years of experience in validation, QC, or commissioning in pharma/biotech
* Advanced English proficiency (C1 Cambridge level or higher)
* Strong written and verbal communication skills
* Solid understanding of GMP and relevant regulatory frameworks
* Experience with aseptic fill/finish, OSD, gene therapy, or biotech processes
What We Offer:
* Competitive salary
* Relocation package: travel support, temporary housing, and financial assistance
* Paid overtime or comp time
* Company phone or reimbursement
* Pension contributions and support for professional memberships
* Ongoing training and development opportunities