MANAGER ENGINEERING OPERATIONS: Manages day-to-day engineering activities to support production schedule.Subject Matter Expert (SME) on facility modification, equipment and utility system design.Assist in Capital Planning efforts which include Project funding justification and governance. Develops Site Master Plan for new projects and utility & production equipment upgrades.Manage/coordinate activities associated with Capital Projects inclusive of developing and maintaining schedules, resources, field supervision of engineering projects and outside contractors, performing system start-up, FAT, SAT, commissioning, qualification, verification and process improvements.Member of Site Change Control representing facility and engineering.Review and approve User requirements, Technical Specification, Basis of Design, General Design Specifications, Detailed Design Specifications, Project Execution Plans, Master Validation Plans, IOQ Protocols, Process Qualification and Validation protocols.Act as Technical SME to provide support to QA during investigations and closure of Corrective and Preventive Actions (CAPA) commitments.Program manager for projects assigned to engineering team.Review and approves Engineering, Maintenance and Metrology SOPs.Design and review complex P&IDS, electrical schematic diagrams, Ethernet network diagrams.Review and approve User requirements, Technical Specification, Basis of Design, General Design Specifications, Detailed Design Specifications, Project Execution Plans, Master Validation Plans, IOQ Protocols, Process Qualification and Validation protocols.Review and approves Engineering drawings and maintain as-built drawing program.Design and review complex P&IDS, electrical schematic diagrams, Ethernet network diagrams. Support the change management system through the completion of action itemsEngieering lead for deviations in area of responsibilitySupport/create corrective and preventive action plansReview functional and criticality assessments for new and existing instrumentsSupports and sometimes leads safety initiativesProvides technical/procedural guidance to technical writerProvides technical guidance to engineering team (requires working in production areas)Maintains training as currentPresents training and other communications to end users on engineering related topicsIs the main technical contact for end users, Quality and Maintenance in his or her area of responsibilityAttends coordination and shutdown meetings as required with end users and othersAssists and backs up other automation engineers. BS in engineering or science related degree with 5 to 10 years relevant experience, or 10+ years of relevant experience, preferably in a large scale biotech or pharmaceutical industry, with a good understanding of current maintenance and metrology best practices and common issues addressed by Automation and Metrology. Frequent movement around the site and into production areas is an essential function of this job.Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively work with cross functional teams.