Coating Technician

The coating technician cleans, sets up, weighs, formulates, mixes and coats according to the requirements of Formulation, Mixing and Coating SOP, Equipment and M.O. Camstar procedures. Collects drug samples as required by TDD MO procedures. Assures that equipment is properly & correctly cleaned, the correct raw materials are used, formulations are mixed exactly per SOP and M.O. requirements, and that all formulation processes are compliant with the established methods and procedures. Ensures that all Formulation, Mixing and Coating lots are completed to meet production timelines and goals. ​Must be able to perform the essential functions of the job, as listed in the Essential Function Analysis Form, with or without reasonable accommodation. ROLE RESPONSIBILITIES • ​​Operates Mixing, Coating and Slitting equipment and assures that correct components are added into the batch in the correct sequence and in the correct amounts per M.O. and CAMSTAR requirements for all products being formulated and manufactured. • Performs coater, slitter and mixing vessel equipment change-over and set-up operations in a timely, efficient, safe, compliant, and accurate manner. • Ensures Coater, Mixer and Slitter equipment are operating under established operating parameters. Any equipment observed as running outside of the established parameters must be reported to the supervisor and Process Engineer immediately. • ​Ensures all products manufactured by the Coater, Mixer and Slitter meets GMP manufacturing specifications. Any deviations from the GMP requirement must be reported to the Supervisor and Process Engineer immediately. • Performs thorough and accurate line clean checks to insure there are no risks of product cross contamination as required. • Performs proper and accurate materials verification as required in the SOP. Ensures all raw materials used are cleared for usage. • Always follow all cleaning procedures that are outlined in department SOP's, MO's CAMSTAR and PROTOCOLS for the Formulation Isolators, Coaters, mixing vessels and Slitting equipment used in the manufacture of batch formulations and Rolls stock products. Reports all or any discrepancies to Supervisor and Process Engineer immediately when discovered. • ​Follows all safety procedures outlined in the EHS SOP for proper grounding and Lock Out Tag Out requirements. Reports any safety equipment failures to supervisor or EHS Engineer immediately. • ​Able to trouble-shoot routine equipment problems and recognize when supervision and maintenance should be notified which contributes to the plant goal of minimizing equipment down time per established OEE targets. • Keeps Coating and Mixing equipment running efficiently and per the production plan; immediately communicates with Supervisor and process Engineers any issues that prevent equipment from running as scheduled. • Maintains and ensures Coating, Mixing, cleaning suites and Flammable storage warehouse is always clean and orderly. Reports any property damage to Supervisor immediately. • Always knows and uses good safety work practices during the scheduled work shift. Takes ownership for ensuring the Coater and Mixers are running a safe operational state, promptly communicates all unsafe conditions in the Coating departments to Supervision and Management. Identifies opportunities for improving safety and actively participates in safety programs. • Operates all material handling equipment in a safe manner and follows all safety plant safety requirements for material handling equipment. • Anticipates and plans for lot kitting, staging, coating, and formulation operations for the efficient transition to the next formulation lot. • Communicates current production activities, schedule changes and equipment status changes of Mixers, Coater, and formulation processes with technicians on all shifts. • Solid understanding and knowledge of in-process product quality requirements. • Ensures all products Formulated, Mixed, Coated and slit are defect free from all contaminates. All defects found must be reported to supervisor and process engineer immediately. • ​Accurately records process and lot information on Shop Orders, MO's, Camstar, PROTOCOLS, logbooks, labels, etc., in accordance with SOP, M.O. and cGMP requirements.BASIC QUALIFICATIONS • ​​Excellent attention to detail is essential. • Must be able to follow written and verbal instructions; able to read, write legibly, understand, and communicate in English. • Must become certified in job performance within the specified amount of time allowed, this also applies to yearly re-certification requirements. • Uses a calculator and have good basic math skills including metric conversions and percentages to perform accurate data calculations. • Report all labor activities accurately into a computerized labor reporting system. • Excellent teamwork & interpersonal skills are required will all coworkers, Engineers, and Supervisors, able to effectively communicate process and equipment information to co-workers, Supervisors and Engineers.California residents should review our Notice for California Employees and Applicants before applying. Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!