Manager, Validation (Fill Finish/Utilities/QC)

CSL Behring
Holly Springs, North Carolina
Sep 25, 2020
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary :
Reporting to the Sr. Manager of Validation, the Manager provides managerial direction and technical leadership for the Fill Finish/QC/Utilities team of Validation Specialists. Manages CQV support of routine operations and projects in Fill Finish/QC/Utilities departments. This includes support for the design, start-up, commissioning and qualification of equipment and associated computer systems, facilities, and utilities. Additional responsibilities include ensuring compliance with Seqirus policies and procedures, managing and developing staff, and financial management and supervision of contractor resources for project support.

Major Accountabilities :
  • Responsible for commissioning and qualification for cGMP equipment and associated computer systems, facilities, and utilities (IOPQ). Validation responsibilities include cleaning, sterilization and decontamination, dirty, clean and sterile hold, and classified space environmental qualification. Facilitates management of validation maintenance assignments within Fill Finish/QC/Utilities on time to meet department objectives and to maintain the areas in a qualified state. Develops and completes CQV deliverables to schedule and budget for projects within Fill Finish/QC/Utilities.
  • Provides strong leadership, direction and organizational planning skills for their team of Validation Specialists. Responsible to mentor and develop their staff technically and professionally. Cascades functional deliverables in alignment with the site and department objectives, providing clear vision of goals and tangible results.
  • Acts as lead presenter during FDA inspections for areas of responsibility/expertise.
  • Ensures creation and implementation of site procedures for a robust and compliant Commissioning, Qualification, and Validation Program. Maintains oversight to develop and maintain applicable Building and/or Subject Matter Validation Master Plans.
  • Interacts with the Quality unit to ensure site facilities, systems and processes remain in a validated state.
  • Other job duties that may be assigned from time to time.

Minimum Requirements :
  • Bachelor's degree is required in Engineering, technical or science related field.
  • 6+ years of progressive experience in qualification & validation of pharmaceutical/biotech operations, with thorough working knowledge of cGMPs, FDA regulatory guidelines, and validation principles required. 8+ years of progressive experience in qualification & validation preferred (6+ years minimum)
  • Demonstrated leadership of projects or teams
  • Working knowledge of FDA expectations around qualification
  • Proven regulatory authority interaction