Process Scientist III
Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022
Job DescriptionJob Purpose:The position will be part of the
Manufacturing Sciences & Technology, Process Sciences team at the
Holly Springs Influenza Vaccine manufacturing facility, supporting
Bulk Operations. The MS&T function provides strategic technical
direction to manufacturing organizations (including 3rd parties) to
achieve supply targets and maximize capacity.This position has
responsibilities that include providing technical expertise related
to the process, equipment, and business systems that support Bulk
Cell Culture, Fill-Finish, or Technology Transfer teams. Major
- Technical Expert for multiple assigned unit operations and
processes in Downstream Bulk Manufacturing operations. Responsible
for the reliability and robustness of assigned products and/or
- Provides leadership, support and guidance to the Downstream
Bulk Manufacturing Suite Team.
- Manages and maintains process monitoring tools (connected to
OSI Pi, LIMS, SAP, etc.)
- Identifies and leads implementation of complex continuous
improvement projects to improve yield, reliability, and process
- Leads the execution of process validations, annual monitoring
batches, and short-term improvement projects, liaising with all the
relevant parties to ensure accurate execution.
- Leads complex product and process related investigations and
deviations including complaints, Out Of Expectation, Out Of
- Provides input to internal and regulatory audits as
appropriate, serving as a lead SME during audits.
- Provides technical information and support training for
process-related matters within production to maximize process
understanding and enhance knowledge-based decision making.
- Ensures protocols are executed as intended and oversees
execution of protocols.
- Uses scientific and statistical knowledge to analyze data to
provide process understanding, and to identify root causes of
product and process failures.
- Drives continuous improvement initiatives to proactively
prevent process failures. Leverages process and compliance
expertise to facilitate cross functional decision making and
- Contributes to Annual Product Reviews and Product Quality
Review for analysis and for contributing to process technology
- Process and equipment owners, providing fit-for-purpose risk
assessments for technology transfers.
- Troubleshoots and investigates equipment and process issues
within the manufacturing facility, coordinating with appropriate
teams to resolve issues and prevent reoccurrence.Minimum
- Bachelor's degree required. Degree in Engineering or Science
- Minimum 5 years of related pharmaceutical/Biotech industry
experience required. 7+ years of experience preferred.
- Experience with cell culture manufacturing preferred.Direct
experience with regulated environments (i.e. cGMP, OSHA, EPA)
required, with direct experience supporting biannual or
- A solid understanding of scientific principles and the ability
to apply your knowledge.
- Advanced troubleshooting skills with ability to mentor
- Strong Process improvement experience, certification in
Lean/Six Sigma preferredAbout UsOur BenefitsSeqirus 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 SeqirusSeqirus 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 usAs a global organisation with employees in 35+ countries,
CSL embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at Seqirus.Do work that matters at
Keywords: CSL Behring, Cary , Process Scientist III, Other , Holly Springs, North Carolina
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