CSL Limited

Senior Engineer, Tech Ops

CSL Limited • $95K — $115K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant branch of Biological Science or Engineering
  • 3-5 years' hands-on experience in process development activities
  • Knowledge of regulations (FDA, EMEA, TGA) related to GMP production
  • Pharmaceutical/biotech experience preferred
  • Local legal and educational requirements may apply.

Responsibilities

  • Lead technology transfer projects across internal sites and external partners as the technical lead.
  • Provide technical expertise for process, equipment, and operational challenges.
  • Author and maintain technical documentation such as transfer plans and compliance documents.
  • Drive project execution through collaboration with cross-functional teams and external partners.
  • Maintain knowledge of processes and equipment to support continuous improvement initiatives.
  • Support Regulatory and Quality compliance activities and documentation preparation.
  • Manage manufacturing readiness activities for successful process implementation.

Benefits

  • Comprehensive well-being support
  • Opportunities for professional development
  • Access to health and wellness resources
  • Collaborative and innovative work environment
  • Engagement in global manufacturing initiatives
Full Job Description
Responsibilities:
  • Lead technology transfer projects across internal manufacturing sites and external partners, serving as the technical lead and ensuring successful execution of project deliverables, timelines, and transfer objectives.
  • Provide technical expertise and manufacturing support for process, equipment, and operational challenges, including troubleshooting, technical investigations, risk assessments, and support of commercial manufacturing campaigns.
  • Author, review, and maintain technical documentation including transfer plans, assessments, procedures, batch records, protocols, specifications, reports, training materials, and related compliance documentation.
  • Drive project execution and cross-functional collaboration by coordinating activities across Manufacturing, MS&T, Quality, Engineering, Regulatory, Supply Chain, and external partners, including CMOs and CDMOs, to achieve project milestones and business objectives.
  • Maintain process, equipment, and automation knowledge to support technology transfer, process performance, and continuous improvement initiatives that enhance yield, reliability, robustness, safety, and operational efficiency
  • Support Regulatory and Quality compliance activities through preparation of technical documentation, support of submissions and health authority responses, and participation in deviations, change controls, CAPAs, OOS, OOE, and complaint investigations.
  • Manage manufacturing readiness activities, including material enrollments, BOM updates, manufacturing system changes, and the planning, execution, and support of engineering, demonstration, and validation batches to ensure successful process implementation and commercialization across a global manufacturing network.


Qualifications:
  • Bachelor's degree in a relevant branch of Biological Science or Engineering
  • 3-5 years' hands-on experience in process development activities
  • Knowledge of the regulations (FDA, EMEA, TGA) associated with GMP production
  • Pharmaceutical/biotech experience preferred
  • Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
  • Refer to local job documentation where applicable.


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.

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

About CSL Limited

CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
Learn more about CSL Limited
Size
25,000 employees
Industry
Pharmaceuticals & Biotech
Founded
1904
NASDAQ
CMXHF
* Ladders Estimates

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