Requisition ID 14324BR
Title Packaging Quality Engineer II
Job Category Quality
Job Description Position Purpose:
Qualify packaging systems and processes associated with changes to existing systems and new capital projects. Prepare, execute, analyze data and write reports for IQ, OQ and PQ packaging protocols. Prepare, execute, analyze data and write reports for revalidation of packing systems and processes. Investigate and resolve all qualification deviations in compliance with local, corporate and regulatory requirements. Support qualification efforts for laboratory systems/processes. Defend/explain validation concepts/approaches with auditors in a professional manner.
Participate in the development/improvement of procedures to support the effective implementation of packaging qualification efforts.
Collaborate with system engineers to implement improvements for systems and investigate and solve packaging related issues.
Lead team efforts to determine root causes for failures related to packaging systems and processes.
Review GMP documentation for packaging and laboratory documents including specifications, change control documents, procedures, etc. ensuring the documents are compliant with local, corporate and regulatory regulations.
Actively participate in Quality Improvement circles to lead process/compliance improvements related to packaging systems and processes.
Education: BS in Engineering, Computer Science or applicable technical degree.
Experience: Minimum 4 years automation experience with a minimum of 1 years experience in the pharmaceutical industry. Must have ability to apply automation knowledge to pharmaceutical applications.
Technical/Process/Functional Knowledge: Knowledgeable in the following automation systems: Programmable Logic Controllers, Supervisor Control and Data Acquisition systems, database systems and automation integration software systems including programming skills and knowledge of validation concepts.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified. Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Department QA Finished Production
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Packaging Quality Engineer II
Job Category Quality
Job Description Position Purpose:
Qualify packaging systems and processes associated with changes to existing systems and new capital projects. Prepare, execute, analyze data and write reports for IQ, OQ and PQ packaging protocols. Prepare, execute, analyze data and write reports for revalidation of packing systems and processes. Investigate and resolve all qualification deviations in compliance with local, corporate and regulatory requirements. Support qualification efforts for laboratory systems/processes. Defend/explain validation concepts/approaches with auditors in a professional manner.
Participate in the development/improvement of procedures to support the effective implementation of packaging qualification efforts.
Collaborate with system engineers to implement improvements for systems and investigate and solve packaging related issues.
Lead team efforts to determine root causes for failures related to packaging systems and processes.
Review GMP documentation for packaging and laboratory documents including specifications, change control documents, procedures, etc. ensuring the documents are compliant with local, corporate and regulatory regulations.
Actively participate in Quality Improvement circles to lead process/compliance improvements related to packaging systems and processes.
Education: BS in Engineering, Computer Science or applicable technical degree.
Experience: Minimum 4 years automation experience with a minimum of 1 years experience in the pharmaceutical industry. Must have ability to apply automation knowledge to pharmaceutical applications.
Technical/Process/Functional Knowledge: Knowledgeable in the following automation systems: Programmable Logic Controllers, Supervisor Control and Data Acquisition systems, database systems and automation integration software systems including programming skills and knowledge of validation concepts.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified. Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Department QA Finished Production
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%