Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

• Coordinate and perform validation projects and protocols in support of process validation of moderate complexity.
• Write protocols and reports.
• Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
• Coordinate activities in support of assigned projects working closely with Quality Systems and Subject Matter Authorities.
• Train and provide support to Operations to ensure protocols are implemented as intended.
• Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting product and process validation.
• Act as a resource to other departments for product and process knowledge.
• Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of moderate complexity.
• Adopts PPI as a culture and as way of life and works with Operations & Quality to drive efficiency and implement future state processes.
• Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
• Performs other duties as assigned.

• Bachelor's degree in Biology, Chemistry, or other similar Life Science field.

• Able to work independently, with mentorship from Technical Operations team.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods.
• Excellent verbal and written communication skills
• Ability to learn new products and technology at a moderate speed.
• Strong laboratory skills and knowledge of safety precautions
• Strong project management and organizational skills.
• Possess a continuous process improvement mentality with the ability to optimally lead and handle change.
• Proficient in use of Microsoft Office Suite.
• Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behaviour (always stay above the line). Embody the Thermo Fisher 4-I Values at all times.

• 3-5 years relevant experience in medical device or pharmaceutical area.
• Previous experience of working with ELISA kits
• Familiarity working within a QMS system and ISO regulations.