Engineer II/III - MS&T Tech Services (Night Shift)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Dec 23, 2020
Ref
R-127875
Required Education
Bachelors Degree
Position Type
Full time
About CSL

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 Manufacturing Sciences & Technology (MS&T) team supporting Bulk Manufacturing Operations. The MS&T function provides strategic technical direction to manufacturing organizations 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 drive strategic improvements within the Bulk Cell culture and purification facility. Provide front line support of production and process-specific issues.

This is a night shift role. Work Hours: 6PM-6AM, Schedule: 2-2-3 and includes every other weekend.

Responsibilities:
  • Provide support to manufacturing as the primary point of contact for technical and operational equipment/process issues. Troubleshoot and investigate equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
  • Maintain ownership of investigation of minor deviations, select major deviations and ensure timely closure through collaboration with Frontline QA.
  • Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity.
  • Supervise and execute technical trials/ engineering run protocols and ad-hoc samples as needed to ensure successful completion and oversight of non-routine work
  • Author and improve existing SOPs, and Work Instructions to improve processes and ensure safe and efficient operations.
  • Provide Hyper-care coordination, implementation and support for new processes and significant changes, such as equipment upgrades or PPQ executions.
  • Interface with maintenance, metrology, engineering, and quality to implement and update preventative maintenance plans, coordinate creation and execution of work orders, and ensure spare part quantities are appropriate.
  • Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution
  • Learn, Understand and work within a matrix organization to drive performance.
  • Active participation in Shift Change and hand off for all critical functions
  • Be a strong partner to the shift supervisors and area managers.


Qualifications:
  • Bachelor degree in Engineering or equivalent in related field preferred or equivalent technical education and experience
  • Minimum 3 years of experience working in the pharmaceutical/biotech and experience must be within cell culture/purification
  • Experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments is preferred
  • Strong understanding of engineering, equipment, and automation principles
  • Strong mechanical aptitude or knowledge of electronic / mechanical equipment is required.
  • High attention to detail in order to solve a range of routine and non-routine problems.


* Level of role will be based on experience and skills.