Technician II - Tech Services

Bora Pharmaceuticals•Maple Grove, MN

7d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. The Technician II – Technical Services supports the Technical Services department through hands-on operation, setup, cleaning, and organization of equipment within the development suites. This role supports development suite activities and provides technical support for development, technology transfer, registration/submission, validation, and commercial manufacturing activities for CDMO clients. The position assists with batch manufacture, equipment readiness, physical testing, cleaning validation, documentation, and cross-functional support to Manufacturing, Quality, Engineering, Maintenance, EHS, and other departments as needed. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. This role requires to be onsite.

Requirements

Two years of college or vocational education, preferably in chemistry, engineering, or a health-related field and a minimum of one year of technical service or development experience; OR a high school diploma / GED with four or more years of pharmaceutical experience.
Knowledge of current Good Manufacturing Procedures, ability to follow written procedures, attention to detail, strong organizational skills, and ability to accurately document observations and test results.

Responsibilities

Maintains readiness of the development suites, including equipment setup, operation, cleaning, room organization, change parts, spare parts, supplies, and general area upkeep.
Maintains, operates, cleans, and supports setup/changeover of development suite equipment used for blending, dry and wet granulation, drying, milling, compression, coating, encapsulation, and other oral solid dosage and liquid unit operations, as applicable.
Coordinates with Engineering, Maintenance, EHS, and other departments to support equipment repairs, calibrations, containment requirements, and development suite readiness.
Prepares experimental, laboratory, and development batches within the development suites and assists with documentation, sampling, process observations, troubleshooting, and technical support for clinical, registration/submission, validation, and commercial manufacturing batches of new or existing products under the supervision of Technical Services Scientists.
Performs sampling and physical testing of products, including but not limited to: disintegration, hardness and friability of tablets, particle size, flow characteristics, and moisture of granulations and powders.
Maintains accurate records, including laboratory notebooks, batch record documentation, experimental data sheets, training records, and supply inventories within the development suites.
Assists with writing, reviewing, and revising equipment procedures, cleaning procedures, batch records, protocols, reports, and other technical documentation.
Assists in the execution and documentation of validation and qualification activities, including cleaning validation swabbing, process validation support, packaging validation support, equipment qualification, and facilities/systems qualification activities, as needed.
Supports technology transfer activities by assisting with process execution, sampling, documentation, process observations, and troubleshooting during development, clinical, registration/submission, validation, and commercial manufacturing batches.
Provides technical support to Operations, Quality Assurance, and other departments as needed.
Assists in the training of technicians.