Engineer - Biotech Equipment

Engineer - Biotech Equipment

System Owner of biotech processing equipment for the Amgen Colorado
Longmont operations. The candidate will be part of an
engineering group that is responsible for applying engineering skills and
experience to ensure the reliability, safety, and quality compliance of
manufacturing and utility equipment for. Specifically, the candidate may
own a combination of process tanks, rotating equipment such as pumps,
agitators, and eductors, chromatography systems, glass-washers, autoclaves and parts
washers, clean-in-place skids and equipment, and associated valves and
instrumentation. Duties and tasks associated with system ownership include
providing engineering expertise to manufacturing and maintenance,
developing and/or revising maintenance strategies, plans, and procedures,
overseeing equipment startup tasks, leading troubleshooting investigations,
supporting safety/compliance investigations, providing technical support to
engineering projects, and managing equipment projects on a small scale.
System owners must work closely with multiple disciplines including
manufacturing, quality, maintenance crafts, utility operators, and validation. A
background in a regulated environment is helpful since all duties and tasks
must adhere to approved procedures and FDA Code of Federal Regulations.

Basic Qualifications
Master's degree
OR
Bachelor's degree & 2 years of directly related experience
OR
Associate's degree & 6 years of directly related experience
OR
High school diploma / GED & 8 years of directly related experience

Preferred Qualifications
Mechanical Engineering Degree and 6 years of related GMP experience.
Strong experience in performing root cause analysis and troubleshooting.
Experience working in an FDA, or other regulated environment and
responding to and/or presenting during regulatory inspections.
Must be able to demonstrate good teamwork, leadership, organizational
skills, and have the ability to adapt to change.
The candidate should have a good breadth of understanding of
manufacturing equipment since specific system responsibilities may shift due
to project and resource demands