Job Description
<b>Job Description Summary</b>The Manufacturing Operations Facilitator plays a critical role in driving continuous improvement, ensuring compliance with industry standards, and enabling teams to achieve high-quality operational outcomes. Collaborating closely with production/quality, facilities and engineering, and management, the Facilitator will proactively identify and address issues while implementing best practices.Additionally, the Facilitator provides leadership and strategic guidance to the Manufacturing teams, ensuring the effective execution of the operational plan in compliance with regulatory requirements (Health Authorities, SOX, OSHA, etc). This includes optimizing efficiency and cost-effectiveness by focusing on process improvements through OPEX initiatives, ramp-up activities, change control management, and document updates.Location: Morris Plains, NJ, LI-#Onsite<br> <b>Job Description</b><b>Key Responsibilities:</b><ul><li><b>Continuous Improvement & Operational Excellence:</b> Lead and manage continuous improvement initiatives and Operational Excellence (OPEX) projects to optimize processes, reduce waste, and enhance operational efficiency. Leverage Lean and Six Sigma methodologies, along with project management techniques, to drive cost-effective improvements and reduce controllable expenses within the department.</li><li><b>Ramp-Up Support:</b> Provide critical support during production ramp-up phases, ensuring smooth transitions and scaling of processes to meet operational demands, while maintaining quality and efficiency.</li><li><b>Change Control Management:</b> Assist in overseeing change control processes, ensuring all modifications are thoroughly documented, reviewed, and approved in full compliance with regulatory and quality standards.</li><li><b>Documentation Accuracy:</b> Maintain and update department-specific documentation, ensuring all records meet internal and external regulatory standards and are up to date and accurate.</li><li><b>Cross-Functional Collaboration:</b> Collaborate closely with the Manufacturing Unit leadership team to support and execute initiatives, ensuring alignment with overall business objectives.</li><li><b>Strategic Planning:</b> Translate organizational goals into actionable strategic plans, enabling the team to effectively plan and execute future activities to meet or exceed targets.</li><li><b>Performance Delivery:</b> Drive continuous improvement in quality, productivity, and cost-effectiveness to ensure the organization remains compliant and competitive in the marketplace.</li><li><b>Team Communication & Engagement:</b> Foster a high-performance, collaborative team environment. Ensure that team members are regularly informed and aligned through effective communication, including team meetings and other updates.</li><li><b>Leadership Support:</b> Act as a trusted partner to area leaders by supporting various leadership activities, including delegation of authority when needed, ensuring smooth and efficient operations.</li><li><b>Quality Culture:</b> Champion a culture of quality throughout the organization, ensuring all team members understand and prioritize adherence to quality standards and regulatory requirements.</li></ul><b>Essential Requirements:</b><ul><li>Bachelor's degree; Advanced degree or specialization certifications is preferred</li><li>Minimum of 5 years' experience in the <span>pharmaceutical/Biotechnology</span> industries with Quality Assurance, Operations, and Management.</li></ul><ul><li><b>Hands-on Quality Assurance:</b> Direct experience in applying quality assurance methodologies and ensuring product and process integrity, with attention to detail in defect identification and resolution.</li><li><b>Regulatory Compliance:</b> Demonstrated experience ensuring compliance with cGMP, USP, FDA, SOX, and OSHA guidelines, particularly in regulated industries such as pharmaceuticals, biotechnology,