Explore Manager Manufacturing, Single Use Systems & Validation jobs and discover a pivotal leadership role at the intersection of advanced biotechnology production and quality assurance. This profession is central to modern biopharmaceutical and advanced therapy manufacturing, focusing on the management of innovative single-use technologies and the critical validation of equipment cleaning processes. Professionals in this field ensure that manufacturing operations are both efficient and compliant with stringent global regulatory standards, such as Good Manufacturing Practices (GMP). Typically, individuals in this managerial position lead a dedicated team of specialists, engineers, and scientists. Their core responsibility is to provide technical leadership and subject matter expertise for the entire lifecycle of single-use systems—from selection and implementation to troubleshooting and continuous improvement. They are also accountable for the site's cleaning validation program, which includes developing and executing master plans, protocols, and reports to prove that equipment cleaning procedures are effective and reproducible. A key aspect of the role involves developing, implementing, and maintaining standard operating procedures (SOPs) and quality system records related to these areas. Day-to-day activities are highly cross-functional. The manager acts as a vital technical liaison, collaborating closely with manufacturing operations, process development, engineering, supply chain, and quality assurance departments. They facilitate risk assessments for processes and equipment, champion operational excellence and lean transformation initiatives, and ensure their team is prepared for new product introductions and technological advancements. A significant part of the role is also people management, including hiring, mentoring, conducting performance evaluations, and developing comprehensive training programs to maintain a skilled and compliant workforce. Common requirements for these jobs typically include a bachelor’s degree in engineering, life sciences, or a related technical field, coupled with several years of progressive experience in biotechnology operations, validation, or a similar GMP environment. Advanced degrees can often substitute for some years of experience. Essential skills include deep technical knowledge of single-use technologies and validation principles, strong leadership and team-building capabilities, excellent problem-solving and communication skills, and a thorough understanding of regulatory requirements. Success in this career demands a proactive leader who can drive continuous improvement, maintain constant inspection readiness, and navigate the dynamic landscape of advanced therapeutic manufacturing. For those seeking to lead in a technically complex and highly regulated field, Manager Manufacturing, Single Use Systems & Validation jobs offer a challenging and rewarding career path.
