Job description summary
the engineering specialist will help with day-to-day engineering tasks needed to support manufacturing sites focusing on activities that can be performed remotely. The role will support automation, commissioning & qualification, process and utility engineering, and maintenance functions.
job description
major accountabilities:
responsibilities:
* work order review
* validation periodic reviews of equipment systems
* system user reviews
* create and revise engineering owned sops
* periodic reviews of engineering owned documents
* deviation and capa ownership and support
* system alarm trending and reporting and any associated investigations
* perform and conduct risk assessments
* equipment kpi metric generation
* change control ownership and action item ownership
* audit trail review
* engineering library management including maintaining the validation document equipment lifecycle index
* site facility drawing updates and management
* project administration and associated metrics
* maintain engineering dashboards
* manage workload to ensure timely approval of validation testing and documentation
* support the engineering department during inspections or audits
* build productive internal/external working relationships
* manage end-to-end document workflows for all types of engineering documents
* exercise good judgment within defined procedures and practices to determine appropriate action
* update and manage all engineering design and project documentation using autocad, revit, bim, navisworks, etc.
* maintain and update all engineering specifications, standards, and design information, including building information modeling data
* other related duties as assigned
requirements:
* b.s. degree in chemical, electrical or mechanical engineering, or related technical field, with 2 years’ work experience in pharmaceutical or biopharmaceutical based gmp manufacturing operations, or equivalent work experience (6 years) in pharmaceutical or biopharmaceutical based gmp manufacturing operations in lieu of degree
* solid foundation in fda regulations and gmp systems and experience providing engineering support in a highly regulated or pharmaceutical/biotech facility
* excellent english oral and written communication skills. Strong technical writing ability required
* experience with full autodesk cad suite
* proficient in microsoft word, excel, powerpoint, teams, and project
* knowledge of equipment and computerized system validation concepts
languages:
* english proficiency
skills desired:
* agile (programming methodology)
* architectural engineering
* aws (amazon web services)
* business continuity
* business networking
* change control
* computer science
* construction management
* cost management
* flexibility
* general hse knowledge
* hvac (heating ventilation and air conditioning), including gdp
* installations (computer programs)
* knowledge of capa
* knowledge of gmp
* knowledge of relevant tools and systems
* manufacturing production
* project commissioning
* project engineering
* project execution
* risk management
* root cause analysis (rca)
* software development
* total productive maintenance
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