Process Engineer III (Cell Culture / Vaccine Manufacturing)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 23, 2021
Ref
R-154529
Required Education
Associate Degree
Position Type
Full time
Job Description

Job Summary:
 

Act as Process Engineer in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects. The role will support the design, procurement, installation of GMP process equipment supporting vaccine manufacturing operations. In addition, the engineer will work closely with internal customers to provide and/or facilitate engineering support for Bulk operations.

Major Accountabilities:

  • Subject Matter Expert (SME) for upstream or downstream process equipment
  • Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems
  • Routinely interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
  • Supports site reliability efforts by monitoring of key equipment performance variables and proactively identifies and addresses issues before they cause unplanned equipment downtime
  • Engage with both internal maintenance personnel and external vendors for issue resolution
  • Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
  • Independently leads small engineering projects
  • Initiate and own change controls for equipment modifications
  • Equipment lead for (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
  • Lead for the execution of start-up and commissioning activities for minor and major equipment upgrades
  • Participate in site audits by health authorities or other regulatory agencies (e.g. OSHA)

Minimum Qualifications:

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering or equivalent preferred with at least 3-5+ years of experience in cGMPs and manufacturing operations in an FDA regulated facility. 
  • Experience with parenteral/aseptic processing preferred.
  • Experience with the procurement, installation and validation of sterile single use systems.
  • Vaccine bulk manufacturing experience.  Experience with bioreactors, ultra-filtration skids and chromatography purification technology.
  • Strong communication skills with customers, design teams, contractors, and management.
  • Action oriented skills; ability to learn on the fly.
  • Good problem solving, technical learning, time management and prioritizing skills.
  • Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems.
  • Routinely interact with manufacturing associates, maintenance staff, QA, validation, and EHS personnel to achieve project and production goals.
  • Supports site reliability efforts by monitoring of key equipment performance variables and proactively identifies and addresses issues before they cause unplanned equipment downtime.
  • Engage with both internal maintenance personnel and external vendors for issue resolution.
  • Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with process equipment.

About Us

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.

About 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.

We want Seqirus to reflect the world around us

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

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