Specialist II, QA Engineering & Validation

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jun 10, 2021
Ref
R-132892
Required Education
Bachelors Degree
Position Type
Full time

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary:

The incumbent will be a member of the QA-Engineering team, supporting QA Engineering activities and programs at the Holly Springs Cell Culture manufacturing facility. 
 The QA-Engineering Specialist applies Seqirus quality principles related to equipment qualification, computer system validation (e-compliance), cleaning, method, and process validation.  Utilizes integrated commissioning and qualification principles to ensure compliance of equipment and system qualification.  Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight.  Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.
 

Major Responsibilities:

  • Ensures that qualification, validation, and technical protocols, and reports comply with site SOPs. Provides review and approval of related documents.
  • Provides QA oversight to equipment qualification, computer system validation (e-compliance), method, process, and cleaning validation including revalidation and re-evaluation. 
  • Provides validation documentation lifecycle oversight.
  • Utilizes data analysis skills and statistical tools to interpret results in support of acceptance criteria and regulatory requirements.
  • Interfaces with customers and partners on quality related issues, participates as the QA representative on multi-functional continuous improvement teams, and ensures efficient and timely project support.
  • Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site. In addition, ensures Good Engineering Practices are followed according to GAMP, ISPE, and Seqirus standards.
  • The QA-Engineering Specialist II will have QA oversight on validation deliverables in QC, Bulk Manufacturing, and Fill Finish collaborating with CQV (Commissioning Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T (Analytical Science and Technology), QC (Quality Control), Manufacturing, and Engineering.

Minimum Qualifications:

  • Bachelor’s degree in Science or Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
  • 3+ years’ experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry or equivalent.
  • Incumbent must possess a solid understanding of computer system validation and equipment qualification.
  • Experience in method, cleaning and process validation and associated deliverables including international regulatory and legislative requirements is preferred.
  • Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site. In addition, ensures Good Engineering Practices are followed according to GAMP, ISPE, and Seqirus standards.
  • Team player developing relationships with key individuals in the work teams, offering assistance and sharing resources with other team members.
  • Experience with e-Compliance/computer validation preferably in a GMP regulated environment within the pharmaceutical industry .