About the role
AI summarisedThis is a mid-level process development engineer role at a biotech company, focusing on new product introduction and process improvements for Array, Library Preparation and Sequencing consumables. The engineer will work with cross-functional teams to develop and scale up processes, troubleshoot issues, and manage change controls under cGMP requirements.
BiotechFull-timeGeneral
Key Responsibilities
- Participate in consumables reagent new products introduction and technology transfers for Array and Sequencing products and processes.
- Participate in process definition, improvement, design, development and quality test activities for development and subsequently scaling up and optimizing new products to production.
- Define and develop technical requirements and procedures for manufacturing to process products.
- Construct and execute controlled experiments to address yield and quality issues and drives implementation of solutions in product development process for pilot and scale up.
- Participate in complex technical issues to establish improvement solutions to correct or prevent recurrence of product and process failure.
- Troubleshoot process development and product transfer issues related to yield, quality, and throughput.
- Support development of key strategic process development program, complete design and projects within schedule, budget and quality constraints.
- Present results and data to collaborators, extended teams on a regular basis and senior management.
- Manage and strategize change controls and assessments according to cGMP requirements.
- Manage non-conformances, deviations and root cause analyses according to cGMP requirements.
Requirements
- Bachelor's Degree in Chemical Engineering, Bioengineering, Chemistry, Material Science or equivalent field.
- Minimum 2 years of related experience in process or product development and project management required.
- Experience in the biotech/pharmaceutical industries is desirable.
- High degree of initiative and ownership while working with several different departments in a fast-paced environment is desired.
- Excellent organizational skills and attention to detail required.
- Proven track record in rational, hypothesis based experimental design, execution and data analysis is desired.
- Demonstrated ability to work independently.
- Ability to effectively troubleshoot and propose next steps.
- Able to apply Statistical Process Control knowledge and DOE techniques.
- Able to analyze data and make logical and rational conclusions.
- Excellent verbal/written communication skills.
- A self-starter, positive, ability to work with ambiguous requirements and driven with a 'can do' attitude.
- Collaborative, open, team player; able to rapidly integrate into global cross functional teams to effectively support progress towards group and platform goals.
- Ability to travel as needed