Sr Associate Operations & Engineering Documentation

ROLE SUMMARY The position is a key member of the Pearl River team, accountable for coordination and management of documentation and documentation systems at the Pearl River site.   The role is a system coordinator for engineering and operations documentation management systems including Computerized Maintenance Management System, Electronic Logbooks System (SDS), Master Batch records and Standard Operating Procedures.   Experienced in Manufacturing of Pharmaceutical/Biotechnology and associated manufacturing equipment. ROLE RESPONSIBILITIES What You Will Achieve In this role, you will: ·         Develops data elements in the CMMS for support of engineering and maintenance including equipment details, maintenance plans, maintenance schedules and work order task plans. ·         Administers CMMS system. ·         Authors, reviews and approves Master Production Batch Records to support manufacturing operations. ·         Authors, reviews and approves electronic logbooks and logbook forms in SDS. ·         Authors, reviews and approves standard operating procedures to support engineering and manufacturing operations. ·         Manages Change Requests, Change Notices and Periodic Review of production and engineering documentation. ·         Coordinates commitment and quality drivers for MBR, FORMS, Maintenance Tasks and SOP updates to ensure requires updates are coordinated, streamlined and efficiently implemented. ·         Reviews and files executed maintenance and production documents in coordination with the QARM documentation group. ·         Manages and reviews data in PGS electronic documentation systems. ·         Coordinates issuance of and reconciliation of cGMP maintenance plans, SOPs, Forms and MBRs, Support regulatory/internal audits. BASIC QUALIFICATIONS ·         Associates Degree with 5+ years experience or BA/BS with  2+ years of experience or MBA/MS with any years of relevant experience. ·         Strong sense of ownership and accountability. Lead change with agility, optimism and innovation. ·         Excellent organization and time management skills. ·         Demonstrated ability to effectively collaborate with team members within and across functions.  Can articulate the issues and solutions to both the PCT and to senior management. ·         Knowledge and experience of cGMP and FDA rules and regulations. • Proficiency in data analysis and trend monitoring with knowledge and experience with technologies digital systems used in the pharmaceutical industry ·         Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use   PHYSICAL/MENTAL REQUIREMENTS Sharp focus, practical and disciplined. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS ·         Occasional need for off hours work (evenings, weekends). Aseptic/Personnel Safety gowning requirements. ORGANIZATIONAL RELATIONSHIPS Close working relationship and matrix management of activities including: Directs interactions across a matrix of functions (Operations, Technical Services, Engineering, Supply Chain, QC and QA) to assure compliant and timely delivery and reconciliation of documentation for manufacturing and engineering/maintenance Routine interactions with site functions including Quality, QC, EHS, Maintenance/Engineering/Automation, Technical Services, Supply Chain, Digital, Procurement and Finance. Matrix responsibility for deliverables coordinating with project teams of up to 5-10 colleagues.    PHYSICAL/MENTAL REQUIREMENTS Sharp focus, practical and disciplined.