Associate Manufacturing Engineer in biotech
RESPONSIBILITIES
• Ability to troubleshoot equipment failures and support resolution
for processing issues
• Ability to independently manage assigned projects and deliver
results with expectations
• Function as technical trainer for enhancing staff knowledge
• Initiate discrepancies, perform root cause failure analysis and
implement corrective action
• Write, modify and implement Standard Operating Procedures
• Initiate change requests for equipment and process changes,
modifications and replacements
• Maintain and report Key Performance Indicators
• Incorporate new technologies, practices and standards into procedure
EDUCATION
• B. S. in technical field, preferably in chemical or mechanical
engineering or acceptable equivalent combination of education and
experience.
EXPERIENCE
• 2-5 years of relevant experience in biopharmaceutical manufacturing,
project management, maintenance or engineering
• Strong technical understanding of tangential flow filtration, depth
filtration, column chromatography, bulk drug formulation, CIP, buffer
preparation, disposables and other aspects of downstream processing
• Working knowledge of process automation and associated equipment
• Proven organizational, leadership and communication skills
• Self-motivated individual, able to work well in a team
• Ability to independently manage work, actions and expectations is
essential
• Ability to solve complex technical problems
• Ability to handle multiple tasks concurrently and be flexible and
adaptable
• Ability to meet deadlines
• Understanding of lean sigma tools and statistical process control;
Green belt preferred
• Understanding of FDA/EMEA cGMP guidelines pertaining to
biopharmaceutical or aseptic processing
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/