|Job Description Job Purpose:
As a Production Engineer you will be responsible for supporting engineering, commissioning, qualification and start-up of the fermentation, purification, formulation and filling processes for a new Cell Culture based Flu Vaccines manufacturing facility in Holly Springs, NC.
Be an integral member of an owner facility design, construction and validation team during the design, construction and start-up phase of the project.
Develop expertise on assigned unit operations. Write standard operating procedures, write batch records, procure raw materials, review design documents, lead investigations, solve problems to root cause, implement corrective actions, operate automated equipment, execute standard operating procedures, execute validation qualifications, train others on unit operations, and lead improvement projects.
Transition into a Manufacturing Operations role upon start-up. Responsibilities will then include:
Ensuring manufacturing goals are achieved through robust safety practices and quality compliance.
Leading deviation investigations and driving continuous improvement
Scheduling manufacturing activities as well as coordinating equipment main-tenance and validation.
Training and technical development of manufacturing staff.
Minimum requirements Requirements:
Bachelors Degree in Chemical or Mechanical engineering or related field
• Minimum 2 years related industry experience required in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles.
A solid understanding of basic engineering principles and the ability to apply your knowledge.
Excellent organizational, planning and time management skills.
Strong oral, written and interpersonal communication skills.
The ability to work effectively in both a team environment and an individual contributor role.
State or Province