Manager, Validation

CSL•Holly Springs, NC

About The Position

Reporting to the Site Head of Validation, the Manager provides managerial direction and technical leadership for the Bulk Manufacturing/Warehouse team of Validation Specialists. Manages CQV support of routine operations and projects in Bulk/Warehouse 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.

Requirements

Bachelor's degree in science or engineering
8+ years of progressive experience in qualification & validation preferred (6+ years minimum required) with thorough working knowledge of cGMPs and validation principles required.
Demonstrated leadership of teams and/or projects
Working knowledge of FDA expectations around qualification
Proven regulatory authority interaction

Responsibilities

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 Bulk/WH on time to meet department objectives.
Develops and completes CQV deliverables to schedule and budget for projects within Bulk/WH.
May include oversight of CQV contractor resources when applicable for projects or backfilling of FTE specialist resources.
Provides strong leadership, direction and organizational planning skills for their team of Validation Specialists and also for contractor resources when required.
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 Quality Assurance to ensure site facilities, systems and processes remain in a validated state.