Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
Performs drug product formulation, filling, crimping, sterilization, Visual inspection, labeling and Packaging. May be required to perform all or a combination of the duties listed below.
Principal Duties and Responsibilities
Buffered solution preparations according to Standard Operating Procedures (SOP’s) Chemical Reactions and RODI Purification of reaction precipitate Lyophilization and high temperature Calcination of harvested precipitate Mechanical Bonding of Nanocrystalline Calcium Phosphate Bone Substitute Material Packaging and assembly of clinical and commercial implantable orthopedic surgical medical device products Shipping procedures and documentation, good written and verbal communication skills Maintain records and clean room environment to comply with regulatory requirements Handling Demineralized Bone (Human Tissue), all training must stay current Cross train in all Manufacturing Processes May be required to perform some of the following: Nitrogen tank replacement and inventory management, assist in quality process document revisions, manufacturing supply ordering and inventory maintenance levels. Moderate exposure to areas that require understanding of SDS & use of PPE to ensure safety
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
• Ability to recognize deviation from accepted practice record keeping • Knowledge of scientific equipment, and operation of manufacturing process equipment • Execution of development and validation protocols for process changes • Environmental monitoring of manufacturing environments • Inventory cycle counting, First-In/First-Out (FIFO) methodology • Proper and safe handling of all wastes considered to be hazardous • Ability to work in ISO classified clean rooms / environments with appropriate required PPE. • Ability to work flexible hours. May require standing for prolonged periods.
High School diploma with 2-4 years experience or Biotech/Biomed Certificate Program or Associates Degree with 0-2 years experience or equivalent combination of education and experience. Some knowledge of cGMP’s, basic chemistry and experience or training in an FDA regulated environment is desirable but not required
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
108,672.00 - 115,875.00 /yearWhat is this?
Process Control Engineer
Process Control Engineer