Validation Specialist II or III (Process)

The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an 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 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.

• Reporting to the Validation Manager (Process), you will support the aseptic validation, cleaning validation, process validation, and shipping validation programs at the CSL Seqirus Holly Springs site. This includes writing protocols, overseeing the execution of protocols on the production floor, authoring protocol deviations, and writing reports. You will participate in regulatory inspections as a subject matter expert.

Travel may be required (10%)

Support and maintain the aseptic validation, cleaning validation, process validation, and shipping validation programs:

• Write and execute validation plans, protocols, and writing summary reports, observing approved procedures.
• Evaluation, implementation, and support of change controls, investigations, and continuous improvement efforts.
• Active member of integrated team where interaction with several groups is required to coordinate, plan, and implement work, including complex changes.
• Ensure that current industry standards are reviewed and implemented
• Support regulatory filings.
• Participate in regulatory inspections.

Provide technical support to the CSL Seqirus network and Contract Manufacturing Organizations (CMO's):

• Provide technical support to CSL Seqirus network sites
• Oversight of tech transfer validation to CMOs

Act as lead presenter during FDA inspections for responsibilities/expertise. Support regulatory filings.

Participate in site and departmental objectives, which may include support of other CQV functions such as equipment qualification.

Other job duties that may be assigned from time to time.

• Bachelor's degree is required in Engineering, technical or science related field.
• 3+ years of experience in qualification & validation of pharmaceutical/biotech operations, with working knowledge of cGMPs, FDA regulatory guidelines, and validation principles.
• Direct experience with aseptic validation, cleaning validation, and/or process validation preferred, however equipment qualification experience or MS&T experience may be suitable for the role.

o Program ownership in one or more of the disciplines

o Knowledgeable on current industry standards

• Previous experience using an integrated qualification approach.
• Interaction with regulatory agencies desired in one or more ways to include:

o Inspection defense

o Authoring responses

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.