UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 17th Aug 2021
This is with GxP equipment in the MFG and QC spaces, so compliance is a MUST.
Awareness and previous experience with change controls, documentation, following and updating SOPs in a GMP environment is required.
They will be working second shift, which there can be some flexibility here, but somewhere between the hours of: 2-10:30 pm / 2:30-11:00 pm / 3:00 – 11:30 PM – so an 8 hour shift with some overlap with first shift to allow for a hand off of activities and training as they come up to speed with the area and work in these spaces.
Job Responsibilities:
Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
Utilize customer systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems with guidance.
Support projects, as a team member, by providing site perspective and helping to minimize impact on ongoing operations.
Provide support for compliance activities which include but are not limited to, audit support and responses, deviations, and investigations in the Quality Management System.
Work with matrix teams, such as manufacturing, validation, quality, network functions, external vendors, and external support teams.
Support activities to improve business and compliance efficiencies.
Provide second shift support for the facility.
Requirements:
BS degree in life sciences, engineering or computer field or equivalent experience.
Preferred 0-2 years of experience working in the BioPharma or similar industry with familiarity supporting benchtop instruments within a GxP compliant manufacturing or laboratory setting.
Comprehensive understanding of Data Integrity guidance, Software Development Life Cycle, and Good Documentation Practices.
Demonstrated leadership skills and the ability to negotiate in a complex environment.
Proven track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.
Excellent verbal and written communication skills.
The ability to plan and lead small and medium size projects and enhancements.
The candidate needs to be self-driven and capable of prioritizing.
The candidate should have a basic understanding of databases, servers, and PCs.
Familiarity with Waters’ Empower 3 and/or Waters NuGenesis, Biovia Lab Execution System (SmartLab), LIMS (e.g., SampleManager) Trackwise and Document Management System is preferred.