Validation Manager

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The successful candidate will ensure products, processes and equipment comply with quality standards and regulations by leading a team of validation engineers and overseeing the validation activities, including testing, documentation, and compliance with cGMP and regulatory requirements for the entire lifecycle within the assigned site.   Role Responsibilities Develop and implement validation strategies and plans (VMPs) to ensure compliance with regulations and standards.  ​Manage and execute equipment, facility, utility and process validation activities for the entire lifecycle within the assigned site.  ​Collaborate with other departments (e.g. Operations, Quality, Automation, Engineering) to ensure alignment on validation activities and provide validation expertise and guidance.  ​Ensure applicable process documentation is created, reviewed and in-place to ensure operation within validated parameters.  ​Ensure proper change control in QTS (e.g. impact assessments, pre-approvals, interim reports and final approvals) are maintained throughout project execution.  ​Participate in internal and regulatory audits for equipment, systems and processes validated in assigned site responsibility.  ​Manage, train and mentor validation staff.  ​Ensure validation activities are consistent with the quality standards, applicable recognized standards, site SOPs and cGMPs.  Basic Qualifications Bachelor’s degree in a science, engineering or related field 8 years of related experience or equivalent combination of education and experience.​ Experience managing direct reports.  Strong understanding of cGMP, FDA regulations and validation principles.  Proficient in MS Office Suite and other relevant software.  Project management experience and skills Strong analytical and problem-solving skills.  Excellent communication and interpersonal skills.