Specialist II/III, (Validation) - Cleaning

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 22, 2021
Ref
R-147968
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Purpose:

Provides validation lifecycle of processes including: Process validation, Aseptic validation, Cleaning validation, and Shipping validation.

Provides support of equipment qualification as needed.

*Level will be determined by years of experience.

Major Accountabilities:  
  • Provide technical input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation, and Shipping Validation:
  • Writing and executing validation plans, protocols, and writing summary reports, in accordance with approved procedures
  • Evaluation, implementation, and support of change controls and investigations
  • Active member of integrated team where interaction with various groups is required to coordinate, plan, and execute work including new facilities or complicated changes
  • Ensures that current industry standards are reviewed and implemented
  • Support regulatory filings
  • Maintenance of lifecycle documentation (e.g. validation plans)
  • Participation in regulatory inspections
  • Provide technical support to the Seqirus network and Contract Manufacturing Organizations (CMO’s):
  • Provide technical support to Seqirus network sites
  • Oversight of tech transfer validation to CMOs
  • Participate in site and departmental objectives which may preclude scope of expertise.
  • Support equipment / automation validation in either QC, facilities, fill finish, or bulk manufacturing
  • Build and maintain relationships with stakeholders including Operations, MS&T, and Quality.
Minimum Qualifications:
  • Bachelor’s degree is required in Engineering, technical or science related field.               
  • Minimum of 5 years of direct validation experience in one or more of the following validation programs: process, aseptic, cleaning, and shipping. 
  • Previous experience using an integrated qualification approach required.
  • Program ownership and/or interaction with regulatory agencies preferred:
  • Inspection defense
  • Authoring responses
  • Strategy building in partnership with Regulatory Affairs
  • Provides input to business problems by sharing functional knowledge with others in own professional discipline
  • Travel may be required on occasion (minimal)

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!