Specialist, Validation

The Opportunity

You will be part of the Commissioning, Qualification, Validation (CQV) team at the Seqirus Flu Cell Culture facility in Holly Springs, NC, and specifically, will be in the Process Validation group. As part of CQV, you will provide technical support in process validation, aseptic validation, cleaning validation, and shipping validation, with eventual program ownership in one or more specialties.

Provide technical input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation, and Shipping Validation. Reporting to the Manager Validation

• You will write and implement validation plans, protocols, and writing summary reports, observing approved procedures
• Evaluation, implementation, and support of change controls and investigations
• Active member of integrated team where interaction with several groups is required to coordinate, plan, and implement work including new facilities or complicated changes
• Ensure that current industry standards are reviewed and implemented
• Support regulatory filings
• Maintain lifecycle documentation (e.g. validation plans)
• Participation in regulatory inspections
• Provide technical support to Seqirus network sites
• Oversight of tech transfer validation to CMOs
• Travel may be required on occasion (minimal)
• Support equipment / automation validation in either QC, facilities, fill finish, or bulk manufacturing

• Bachelor's degree is required in Engineering, technical or science related field. Or equivalent experience
• 5+ years of validation experience
• Direct experience with process validation, aseptic validation, cleaning validation, or shipping validation required
• Program ownership in the disciplines is required.
• Knowledgeable on current industry standards
• Interaction with regulatory agencies desired in one or more ways.
• Inspection defense
• Author responses
• Strategy building in partnership with Regulatory Affairs
• 5+ years of validation experience in the following validation programs: process, aseptic, cleaning, shipping.
• Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire

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.

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.

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