Senior It Gmp Systems
Senior gmp systems analyst: this is a full-time employment opportunity onsite in seattle washington, usa.
designs, implements, and maintains in-house gmp information systems and network software architectures to support gmp processes that meet all customer, business and regulatory requirements through the following activities:
- people focus
- gmp focus
- operational reliability focus
- operational efficiency focus
***primary duties and responsibilities of the position***:
- provides strategic direction for gmp it operations
- defines gmp it standards for services, systems, hardware, and security
- develops, manages, implements gmp it improvement projects
- develops and maintains standards for procedures and maintenance plans
- gmp systems support: implementation, maintenance, documentation, problem resolution & rca
- operations support: gmp process and operational support
- hardware life cycle management
- promoting a safe work environment
- attainment indicators:
- it gmp compliance
- restore lost function
- standardization of processes
- project support rft
- safe working environment
- other duties as assigned.
- bs in it/is or related field / equivalent experience.
***experience and critical skill requirements***:
- 3-5 years computer related support and systems administration experience in design, implementation, and maintenance troubleshooting hardware, operating system, and network issues.
- 5-7 years it validation or qa it experience, including: support and troubleshooting scientific instruments such as cedex, nova, and akta, technical writing of system documentation and configuration management, systems monitoring and auditing, computerized system validation, disaster recovery and business continuity planning.
- proven expertise in project management – planning/organization/execution of it systems lifecycle management – from rfp to retirement.
- performs varying complex duties with little/no direct supervision. Can work on long-term issues & projects where little/no instructions or guidelines exist. Able to multi-task on several projects while maintaining daily activities. Ability to manage projects and achieve desired results within specified deadlines, and revising the work plan for complex problems being resolved by cross functional teams.
- working knowledge and practical experience of computer and application integration / validation (preferably using gamp methodology), cgmps, and 21 cfr part 11 in an fda regulated environment
- knowledge of software testing (fat / sat) and commissioning procedures
- ability / experience in managing cross functional it / process automation projects
- ability to work hours necessary to support production and /or maintenance activities across multiple sites.
- ability to lift up to 40 lbs. With assistance.
- ability to work in confined spaces and near operating equipment.
- ability to work in loud noise environments
- mentorship responsibility for it staff as well as peers.
- responsible for indirect oversight of project team staff when assigned as project team leader.
***competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.
***kindly provide a brief summary of your relevant experience and attach your latest cv along with your response.
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