B57 Prep/Tank Senior Technician

B57 Prep/Tank Senior Technician

Requirements

• Requires good mechanical skills, computer skills and is detail oriented.
• Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
• Prior or related cGMP or Pharmaceutical experience recommended.
• HS diploma or equivalent and 2+ years in cGMP or Pharmaceutical experience.
• Associate’s with 1+ years in cGMP or Pharmaceutical experience.
• Bachelor’s degree.
• Proficiency in at least but not limited to three areas of operations or product line.
• Must be a qualified trainer in one or more areas.
• Must be proficient in at least one of the following areas: Utility Sampling, equipment prep, tank movement.
• Must have knowledge and access to systems (SAP, Master, SCADA, RT Reports, Labware).

Responsibilities

• Must be flexible to ensure staffing for changing business volume and needs.
• Maintains training for and completes closed system connections and sampling requirements.
• Coordinates movement of bulk product with managers.
• Completes wetting and testing of process related filters.
• Performs routine inventories and escalates missing equipment/materials to senior or management.
• Consults schedule on a routine basis and ensure all parts and materials are available.
• Ensures segregation of components.
• Maintains aseptic gowning.
• Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc).
• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.
• In on time and attends and participates in Shift Change.
• Must be able to be complete and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP.
• Participates in production process (SAP, Labware if required, Trackwise, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.).
• Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them.
• Works with senior technician and managers to ensure continuous operation.
• Assists with identification and closure of area irritants.
• Use and completion of OMS tools.
• CIP of Palltronic.
• Tank checks, hook ups, and disconnections.
• Weekly tank mixes.
• Water sampling.
• Loading and unloading of autoclaves.
• Washing and wrapping of parts.
• Commodity movement in prep.
• Disinfectant preparation.
• Maintains training for and completes Grade B EM, cleaning, and SAP.
• Performs routine inventories and escalates missing equipment/materials to management.
• Consults schedule and ensures appropriate cleanings are completed.
• Training of all new technicians.
• Documentation review.
• Coordination of breaks.
• Ensures operational area is always adequately staffed.
• Strive to become experts in their assigned areas.
• Works with lead/senior technicians and managers to ensure continuous operation.
• Assists with identification and closure of area irritants.
• Use and completion of OMS tools.
• Commodity/inventory management.

Preferred Qualifications

No preferred qualifications provided.