Quality Engineer Ii

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION

• BS/ BA in biology, biochemistry, chemistry, or other science related field

EXPERIENCE

• 1+ years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.
• 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals
• Preferred experience in either upstream or downstream processing
• Preferred experience facilitating meeting with cross functional teams
• Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operational Excellence tools
• Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES

• Solid technical writing skills required.
• Solid communication skills.
• Ability to drive functional, technical, and operational excellence.
• Ability to evaluate data and make recommendations based on data.
• Ability to make recommendations based on trends and trend analysis.
• Ability to work in a fast-paced environment with the ability to prioritize effectively to meet timelines.
• Facilitation skills for groups including staff level employees.

• Assume site level responsibility for all site investigations including items originating from Production, Quality Control, Facilities, etc.
• Provide written documented investigations in an appropriate and timely manner.
• Coordinate and facilitate events with cross functional teams to evaluate causal factors, execute root cause analysis, and ensure CAPAs are put in place to reduce or eliminate recurrence of issues.
• Work with direct guidance and oversight to get results, meet timelines, and improve processes.
• Effectively communicate with peers and colleagues regarding status of investigations and recommendations based upon investigation outcomes.
• Participate in client communications and responses with oversight team leads and management
• Collaborate with QE III to provide feedback for concurrence meetings
• Active participant in Tier I huddle