Technical Services Engineer I/II, (24/7 Manufacturing Support Team) -Day Shift

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jul 20, 2021
Ref
R-137961
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 Purpose:

The incumbent will be a member of the 24x7 Manufacturing Support Team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk Operations.

Provides troubleshooting expertise to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical support related to the process, equipment, and business systems across all departments within Bulk Manufacturing. This function acts as front line support of production and process-specific issues.

  • Shift Days
  • Hours: 6am -6pm
  • Schedule: 2, 2, 3 every other weekend off

Major Accountabilities:
  • Provide support to manufacturing as the first line 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.
  • Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related CAPAs.
  • 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. Identify and implement continuous improvement projects to ensure safe and efficient operations.
  • Learn, understand and work within a matrix organization to resolve issues and drive performance
  • Own or assist with investigations related to product and process including complaints, deviation, or adverse process trends within Bulk Manufacturing.
  • Coordinate with vendors, MS&T and supplier management for third party complaints.
  • Interface with maintenance, metrology, engineering, MS&T and quality during troubleshooting of manufacturing issues.

Periodic Responsibilities:
  • Ensure protocols are executed as intended

  • Support execution of process validations and annual monitoring of batches

  • Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution


Minimum Requirements:
  • Bachelor’s degree or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred.  

  • Degree in an engineering or science discipline preferred.
  • Minimum 1 year of related industry experience required in the pharmaceutical/biotech industry
  • 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.
  • Proven organization, presentation, and time management skills.
  • Willingness to learn all areas within Bulk Manufacturing and the different systems required to support continuous improvement.