- Generation and revision of documentation associated with electronic manufacturing records and logbooks such as functional specifications, process flow charts, risk assessments, and equipment and facility procedures for specific manufacturing process units.
- Generation and revision of electronic manufacturing records and electronic logbooks and supporting testing and qualification activities.
- System ownership tasks such as performing change control assessments, ensuring appropriate system maintenance is setup and executed, performing vendor coordination for system support, upgrades and also ensuring vendor support agreements are established and maintained. Managing change controls to ensure system is maintained in a compliant manner.
- Performing manufacturing investigations, problem solving, root cause analysis, and implementing process improvements, CAPAs, Change Controls, and Safety Improvements.
- Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing
- B.A./B.S. in a Life Sciences or Engineering degree and 0-2+ years relevant experience or equivalent education and experience.
- Experience working with an MES (Manufacturing Execution System) like. PAS-X, MODA-ES, or Tulip.
- Experience with Agile Methodologies.
- Experience SQL Server.
- Experience with Allen Bradley PLC's.
- Experience in Process Design/Development.
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Manufacturing Execution System Engineer I/II - Durham, United States - KBI Biopharma
Description
Position Summary:
The manufacturing execution system engineer on the technical support and investigations team will support the startup and ongoing manufacturing operations at a new biopharmaceutical manufacturing facility. During startup the individual will be responsible for supporting the introduction and qualification of the MES system at the facility. The individual will report to the director of technical support and investigations.
The individual will be responsible for being one of the MES system specialists for the site. The ideal candidate will have experience with pharmaceutical manufacturing execution and automation systems. Familiarity Allen Bradley PLC's, OSI PI Historian, SQL Server, and Inventory Tracking Systems is desired. Familiarity with SQL, C-like syntax, and Excel Macros is also desired. Additionally, experience in support or operations for the startup and ongoing operations for a commercial GMP mammalian cell culture facility is highly desired.
The engineer should possess proven technical writing and problem-solving skills and a drive for continuous improvement. Additionally, experience with manufacturing deviation, CAPAs, and change controls in a GMP manufacturing facility is desired.
From a technical perspective, the individual will be responsible for supporting MES activities such as generating electronic logbooks, generating electronic manufacturing records, generating functional specifications, setting system standards, providing system training and expertise, and owning and managing system change controls and upgrades.
From a compliance perspective, the individual will be responsible for performing thorough and robust manufacturing investigations, implement effective corrective/preventative actions, and manage manufacturing change controls.
The individual is responsible for working cross-functionally with the manufacturing departments, QA, MS&T, engineering, supply chain, IT, AFS and other key departments to ensure manufacturing operations are successful, reliable and compliant. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.
Position Responsibilities:
Position Requirements:
Preferred Competencies
Salary: Engineer I - $65,000-$80,000
Engineer II - $80,000-$95,000
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
