Motivated to support a new commercial manufacturing facility, an industry-experienced Validation Engineer is sought to lead commissioning, qualification, and validation projects for equipment, utilities, and processes.
As a key team member, responsibilities include leading C&Q activities, supporting technology transfer, developing protocols, managing vendor coordination, and ensuring compliance with cGMP, FDA, and EU standards.
Required skills include knowledge of GMP guidelines, regulatory requirements, validation planning, and cross-functional communication.
Ideal candidates have a bachelor’s degree, 8+ years of validation/engineering experience in pharmaceutical manufacturing (preferably oral solid dose), and familiarity with industry regulations.
Physical demands involve working in office and manufacturing environments, with some lifting. Compensation is based on experience, with benefits including paid time off, health plans, retirement contributions, and wellness programs.