Appleton, WI
Ongoing through Thursday, August 23, 2012
Company: Kelly Services
Contact: Lauren Sell
Job Description: The Manufacturing Engineer will support the assessment and improvement of manufacturing and packaging processes, procedures and documentation across Customer site. The individual will provide support as a subject matter expert for the QSE 10 Workplan related activities as required by the Consent Decree. Responsibilities: • Serve as Subject Matter Expert for Manufacturing and Packaging processes, procedures, batch records and production documentation (Material Weighing thru Finished Product to Warehouse) • Incorporate cGMP, Quality & Compliance standards into all phases of Operations where required • Review, assess and provide input to process and procedure changes/improvements • Project team support (meetings, facilitation, reports/position papers, process development/assessment, etc.) • Review and become familiar well versed with applicable Quality Standards, Standard Operating Procedures (SOP’s) and functional documents/operational guidelines. • Review relevant Assessment GAPs and other observations. • Tour manufacturing/packaging operations relevant to project commitments and become well versed in area work flows (personnel, material, equipment) • Attend and participate in project team meetings (facilitate or lead, document agreements/follow-ups, when needed). • Lead and/or direct the execution of project plans/activities per the exact commitments in the Work Plan. • Read, assess and change/improve/create (where required) Standard Operating Procedures to align with the applicable Quality Standard(s). In addition, work with cross site personnel to ensure procedures are consistent from site to site. • Direct and/or lead SOP review and approval process • Lead and/or support Process Mapping exercise and the effective deployment and use of all Process Excellence (PE) tools for applicable processes. • Collaborate with departmental personnel to understand processes, gather information, analyze processes, address issues, resolve problems and implement change. • Interface with other QSE team to obtain relevant customer/supplier requirements. • Procure and complete documentation required for any changes/improvements per functional/departmental requirements (change control, procedure updates, document changes, etc) • Communicate roadblocks/issues immediately to team lead. • Manage, change, and update project plans based on team progress. Immediately communicate to team lead any risks for meeting commitment dates. • Lead team in gap assessment of standard requirements versus as is system. • Participate in brainstorming sessions to identify root causes of gaps/observations and corrective actions. • Review production batch records, when necessary, to ensure alignment with procedures and quality standards. • Partner with Pharmaceutical Technology and/or Engineering to identify critical equipment operating parameters and critical product/process parameters. • Leads and/or supports role of Change Agent to foster transformational improvement of GMP compliance and efficiency. • Lead/support requirements for compiling documentation for evidence binders. • Lead/support coordination of training for remediation changes and to be system improvements
Job Industry: Engineering
Employee Type: Full-Time, Contracted
Travel Required: None
More info: kelly.bullhorn.staxapps.net…
Ongoing through Thursday, August 23, 2012
Company: Kelly Services
Contact: Lauren Sell
Job Description: The Manufacturing Engineer will support the assessment and improvement of manufacturing and packaging processes, procedures and documentation across Customer site. The individual will provide support as a subject matter expert for the QSE 10 Workplan related activities as required by the Consent Decree. Responsibilities: • Serve as Subject Matter Expert for Manufacturing and Packaging processes, procedures, batch records and production documentation (Material Weighing thru Finished Product to Warehouse) • Incorporate cGMP, Quality & Compliance standards into all phases of Operations where required • Review, assess and provide input to process and procedure changes/improvements • Project team support (meetings, facilitation, reports/position papers, process development/assessment, etc.) • Review and become familiar well versed with applicable Quality Standards, Standard Operating Procedures (SOP’s) and functional documents/operational guidelines. • Review relevant Assessment GAPs and other observations. • Tour manufacturing/packaging operations relevant to project commitments and become well versed in area work flows (personnel, material, equipment) • Attend and participate in project team meetings (facilitate or lead, document agreements/follow-ups, when needed). • Lead and/or direct the execution of project plans/activities per the exact commitments in the Work Plan. • Read, assess and change/improve/create (where required) Standard Operating Procedures to align with the applicable Quality Standard(s). In addition, work with cross site personnel to ensure procedures are consistent from site to site. • Direct and/or lead SOP review and approval process • Lead and/or support Process Mapping exercise and the effective deployment and use of all Process Excellence (PE) tools for applicable processes. • Collaborate with departmental personnel to understand processes, gather information, analyze processes, address issues, resolve problems and implement change. • Interface with other QSE team to obtain relevant customer/supplier requirements. • Procure and complete documentation required for any changes/improvements per functional/departmental requirements (change control, procedure updates, document changes, etc) • Communicate roadblocks/issues immediately to team lead. • Manage, change, and update project plans based on team progress. Immediately communicate to team lead any risks for meeting commitment dates. • Lead team in gap assessment of standard requirements versus as is system. • Participate in brainstorming sessions to identify root causes of gaps/observations and corrective actions. • Review production batch records, when necessary, to ensure alignment with procedures and quality standards. • Partner with Pharmaceutical Technology and/or Engineering to identify critical equipment operating parameters and critical product/process parameters. • Leads and/or supports role of Change Agent to foster transformational improvement of GMP compliance and efficiency. • Lead/support requirements for compiling documentation for evidence binders. • Lead/support coordination of training for remediation changes and to be system improvements
Job Industry: Engineering
Employee Type: Full-Time, Contracted
Travel Required: None
More info: kelly.bullhorn.staxapps.net…