Equipment & Process Technician II (1:30 pm-10 pm)

Nature and Scope The Equipment and Process Technician II works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform inspection area setup, of automated equipment and manual inspection processes, labeling and packaging equipment and process duties, line clearances and assist with inspection/packaging schedule. The Technician will be responsible for maintaining inspection and packaging equipment for changeover and adjustments. In conjunction with the Supervisor, the Technician will provide input and assistance to other Departments as needed. The Technician plays a critical role in assuring safe, effective and compliant activities are performed in the inspecting and packaging area and plays a critical role in maintaining production schedules. The Equipment and Process Technician II will be proficient in all activities associated with the inspection and packaging process and be able to work with minimal supervision. The Technician will receive direction, training, and mentorship from the Supervisor of Inspection and Packaging. The Technician will with assistance from the Supervisor, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Technician will be able to select parameters requiring Supervisor Approval from some manufacturing technologies using the HMI-PLC/SCADA control/data systems. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. - Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. - Maintains accurate and complete records. - Maintains an accurate and complete Training Record. - Ability to set-up and program automated Inspection and Packaging equipment with little to no assistance. - Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities. - Physically performs inspection and packaging reconciliation and provides documentation oversight and acknowledgement for such activities. - Assists with training of new personnel within the department. - Ability to mentor other Technicians in all facets of the inspection process. - Ability to assist the Supervisor in the planning of inspection and packaging activities on a daily, weekly and long term schedule. - Ability (in conjunction with Supervisor) to assign equipment, rooms or personnel to meet required production schedule. - Ability to troubleshoot any problems that might arise. - Ability to review executed batch records and log books prior to submitting for final Production review. - Provides accurate and complete assistance to Quality Assurance as needed. - Works in a safe and effective manner. - Identifies and reports unsafe and non-compliant conditions. - Maintains work space in a clean and orderly manner. - Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent preferred. Technical Training or Bachelors' Degree is a plus. Minimum 3 years' experience in inspection, packaging, quality control and/or production preferred Require/Preferred Experien