Provides scheduling support and operational oversight to day-to-day manufacturing production.
Tracks, trends, analyzes and reports performance parameters and in-process controls.
Works with the CI, MS&T, and QA functions to apply LSS problem-solving and value stream management methods.
Oversees the process for ongoing CI assessments in the fill/finish organization.
Represents the manufacturing organization in defining user requirements and practical implementation of eBRs and integrated systems.
Provides technical leadership over fill/finish processes to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
Develops on job trainings for fill/finish manufacturing associates. Participates in training activities, managing individual training plan.
Assists manufacturing associates to meet batch record review/disposition schedule to adhere to lot release dates.
Identifies root cause, and recommends and implements actions and participates in quality remediation plans.
Executing root cause investigations, owning/authoring deviations, CAPAs and CC
Drives continuous improvement efforts and other quality reports and revising GMP documents such as SOPs and Manufacturing batch records.
Participates and represents fill/finish in cross-functional efforts for deviation reduction.
Conducts data gathering, trending, and data presentation as needed to support investigations. Provides real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
Performs other duties as assigned.
Qualifications
Master’s degree in a Scientific, Engineering or Biotech field with 2 years of experience in aseptic filling manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) OR
Bachelor’s degree in a Scientific, Engineering or Biotech field with 4 years of experience in aseptic filling manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field). OR
Associate’s degree or HS Diploma with 5-6 years of experience in aseptic filling manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
Knowledge of EU Annex 1, GMP’s, FDA regulations and documentation procedures required.
Previous experience operating equipment such as: peristaltic or piston pump aseptic fillers, automated packaging lines, semi-automated visual inspection stations, autoclaves, parts washers, and filter integrity testers.
Previous experience in process deviation investigations and Previous experience authoring and/or revising technical documents.
Experience as a MES, EMS, MRP, LIMS, or LMS user and basic programming skills a plus.
Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.
Excellent communication and technical writing skills and can support and/or lead system troubleshooting efforts.
Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.
