Manufacturing Specialist
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Apply Now Application ends in 27d 20h 11min
Job Detail
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Offered Salary 0
Job Description
The Role:
- Provides scheduling support and operational oversight to day-to-day manufacturing production.
- Creates and reports performance success metrics.
- 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 assessment of the larger manufacturing organization.
- Represents the manufacturing organization in defining user requirements and practical implementation of eBRs and integrated systems.
- Provides technical leadership 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 specialized trainings to assist in technical knowledge transfer.
- Assists manufacturing associates to meet batch record review/disposition schedule to adhere to lot release dates.
- Identifies root cause, recommends and implements actions.
- 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 manufacturing 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.
- Participates in training activities, managing individual training plan.
- Performs other duties as assigned.
The Candidate:
- Master’s degree in a Scientific, Engineering or Biotech field with 2 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
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- Bachelor’s degree in a Scientific, Engineering or Biotech field with 4 years of experience in biopharmaceutical 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 biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- Proven analytical/ problem solving capabilities.
- Proficiency in computer/business systems applications.
- Knowledge of GMP’s, FDA regulations and documentation procedures required.
- Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment a plus.
- Previous experience in process deviation investigations
- 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.
- Ability to support and/or lead system troubleshooting efforts.
- Creative thinking with the ability to multi-task.
- Commitment to ongoing professional development.
- Team player who thrives in collaborative environments and revels in team success.
- 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.
Apply Now
Application ends in 27d 20h 11min