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.