The Senior Manufacturing Technician (SMT) performs, with minimum supervision, routine and non-routine manufacturing operations, including but not limited to reagent formulation, product testing and validation, equipment calibration, etc. The SMT also will be involved in Design Transfer Activities to include process definition, process characterization and process verification/validation.
Essential Duties and Responsibilities:
- As part of the manufacturing team, work closely with R&D and Quality during the development of new products to ensure a smooth transfer of products into reagent formulation.
- Assist with development and implementation of economical, repeatable manufacturing processes for new and existing products.
- Manufacturing of product as scheduled.
- Adhere all applicable SOPs and other requirements affecting manufacturing
- Responsible for product quality and helping resolve quality problems.
- Suggest process improvements for the production cycle; identify and troubleshoot process issues.
- Follow all applicable safety standards and policies.
- Adheres to operator instructions. May assist with training other operators
- Partner with various departments to investigate the root causes of process problems and implement problem specific corrective actions.
- Able to work independently with some supervision.
Qualifications: Education and Experience:
- BS in molecular biology, microbiology, biochemistry, biology, chemistry or related discipline with
- Minimum of 5 years of experience in medical device processing/manufacturing engineering/product development.
- Demonstrated knowledge of Molecular Biology and/or Microbiology
- Experience in cGMP preferred
- Ability to work in a fast-paced environment with multiple priorities
- Experience in shops using Lean manufacturing, Six Sigma, Minitab desirable