Process Engineer II

This position will be for a M-F ~8am-5pm Position supporting the Filling area. This position requires on site work in Holly Springs, NC and will involve supporting an on-call rotation. The position will report to the Sr. Manager Processing Engineering Fill Finish and work to support operations and equipment in the area.

Responsibilities:

• Works independently with general supervision in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects

• Manages from concept and scoping phase, design, preparation of specifications, appropriation requests, through to procurement, installation and start up phases for capital, expense and lease additions to a facility

• Assures compliance with FDA, EPA, and OSHA requirements during all phases of assigned projects

• System ownership of PFS high speed filling line,

• Support deviation investigations and interface with equipment owners and stakeholders

• Owns Actions in Trackwise change management system

• Maintains Documents in Veeva GDocP System

Qualifications:

• MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred

• 3+ years practical experience in pharmaceutical industry in Manufacturing, Engineering or Quality Assurance

• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility

• Understanding of project management principles and project lifecycle phases. Knowledge of Validation, CMC and facility regulatory submission requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus