Manager of Validation

Join a dynamic team as a Manager of Validation! In this pivotal role, you will lead our Validation department, overseeing and driving engineering projects from inception through to completion. You will manage resources, coordinate efforts, and facilitate project progression, ensuring successful outcomes at every stage. If you are passionate about leading teams and making a significant impact, read below and apply in to get a conversation started!

Key Responsibilities:

• Lead and manage the Validation department, including Technical Services employees and other personnel on a project-by-project basis.
• Oversee, manage, and support calibration programs for facilities, including production equipment, facility equipment (boilers, HVAC systems, water systems, etc.), and other instruments.
• Generate, update, and approve Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) checklists, as well as write technical protocols and reports.
• Report on performance outputs and project updates, communicating with diverse internal and external audiences.
• Manage and support Change Control, Deviation, and Corrective Action/Preventative Actions (CAPA) development, investigations, approval, and implementation within the Validation department.
• Develop and uphold the site's cleaning validation program and strategy.
• Review and revision of existing cleaning processes to identify improvements.
• Develop and implement process improvements to enhance system performance.

Key Qualifications:

• Bachelor's degree in Engineering or a related field (Master's degree preferred).
• At least 5 years of experience in validation including cleaning validation and process validation.
• Must have experience working in FDA and cGMP environments.
• Experience in formal and non-formal leadership related responsibilities preferred.
• Exceptional time management and organizational skills.
• Strong written and verbal communication abilities, along with excellent employee relations skills.