Understands aseptic technique concepts Able to operate and maintain equipment Performs solution and material preparation Possesses basic technical knowledge and background Participates on and performs technical transfer activities Assists with the execution of validation activities Receives and organizes materials Identifies and communicates material discrepancies Uses some support systems (e.g. LIMS) Understands the concept of manufacturing processes and methods Collects and records scientific and process data per good document practices Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) Follows and executes Standard Operating Procedures (SOPs) Follows and executes Batch Records (BRs) Participates in the development of technical documents such as non-conforming events and deviations Possess basic computer skills and able to efficiently use basic Microsoft applications Suggests continuous improvement ideas Identifies technical problems Participates on regulatory inspections and client audits Interacts on a minimal basis with groups that support manufacturing Cross trains in other areas and may be utilized to perform above job functions across the entire site Performs well under direct supervision