Engineer II, QA

Education and Experience

• Bachelor's Degree (BA / BS) in Life Sciences (biology, chemistry, biochemistry), Engineering, or another science related field combined with a minimum of three (3) years of relevant experience is required
• Experience with cell culture, protein purification, formulations, or facilities / utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
• Cleanroom manufacturing experience is highly preferred along with a comfort level with full ISO 5 and ISO 7 gowning requirements
• Non-science degrees will be considered if combined with a minimum of seven (7) years of directly related work experience in biopharmaceutical manufacturing

Knowledge

• Understanding ‘why’ and not just the ‘how’ of processes and practices
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
• Experience with investigational writing software system (Track Wise) along with root cause analysis tools utilized in deviation investigations
• Technical writing skills and the ability to write / revise procedures in document management software
• Tech transfer experience is a plus
• Experience with Lean Manufacturing and Six Sigma methodologies is a plus
• Excellent problem-solving and analytical skills

Skills

• Analytical, critical thinking, and problem solving skills
• Strong interpersonal skills
• Strong written and oral communication skills
• Strong math skills
• Strong attention to detail
• Strong Microsoft Office skills (especially Word and Excel)Solid time management and organization skills

Abilities

• Understand and carry out instructions
• Effectively multi-task
• Work effectively in a dynamic environment
• Able to work under pressure
• Able to work independently
• Demonstrated ability to lead others
• Able to coordinate workload for junior team members
• Able to understand departmental as well as site priorities
• Ability to collaborate with colleagues at all levels of organization

Physical Requirements / Work Environment

• Lifting
• Able to gown, wear PPE, and work successfully in a clean room environment

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.