Specialist I, Validation

CSL•Holly Springs, NC

10d•Onsite

About The Position

Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Requirements

Bachelor’s degree or equivalent; education preferably concentrated in Engineering or Science
0-2 years' experience in commissioning, qualification, and/or validation

Responsibilities

The Validation Specialist I is responsible for validation lifecycle activities for equipment, facilities, utilities, QC instruments, and computer systems using an integrated commissioning and qualification approach.
Uses SOPs to develop validation protocols and summary reports.
Executes protocols and collects samples in support of qualification/validation studies.
Leads simple deviation investigations utilizing root cause analysis and investigation tools.
May own corrective/preventative actions.
Programs and calibrates temperature monitoring equipment (Kaye Validator, Lives loggers) for use in qualification protocols.
Coordinates validation activities with the appropriate system owners and other affected departments.
Integrates validation maintenance activities into site schedules.