Process Engineer II, III

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.

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis 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 and CSL Plasma at Benefits

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

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