The candidate should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently with minimal direction and have excellent communication skills.
Responsibility
Approximate % of Time
- Supporting Customer Site Visits and Tours (40 %)
- Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports. (10 %)
- Compiling process data and supporting continuous process verification (20 %)
- Supporting investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation (5 %)
- Supporting collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports (5 %)
- Assist in tech transfer program deliverables (20 %)
Minimum Requirements :
1.1Knowledge, Skills, Abilities
BS or MS in Science or Engineering with minimum of 2 years industry experience (Monoclonal Antibody Manufacturing experience is preferred)Working knowledge of downstream processing techniques and equipment in biologicsUnderstanding of cGMP compliance requirementsExperience with manufacturing operations, tech transfers or scale up is a plusExperience working in cGMP manufacturing environment is preferred1.2Language Ability
Strong proficiency in English and overall communication skills are required to effectively communicate the clients1.3Reasoning Ability
Strong engineering and scientific reasoning skills are required1.4Math Ability
Strong math skills are required1.5Physical Demands
Position requires limited physical demands1.6Computer Skills
Strong computer skills are required particularly in all MS Office programs1.7Equipment Use
Some equipment operation and testing is required or at the least knowledge of equipment operations is required for effective troubleshooting of process issues.