STERILIZATION ENGINEER

Job Title : Sterilization Engineering / Sterilization Validation Maintenan

Location : Swiftwater, PA

Duration : 3 years

Organization / Business Function Background

The Sterilization Engineering / Sterilization Validation Maintenance organization provides subject matter expertise as well as leadership and execution of moist heat, dry heat, VHP sterilization and decontamination activities for new and modified equipment and utilities.

They are responsible for the consistent application of sterilization and decontamination procedures, templates, and standards as well as engineering best practices as it applies to sterilization and decontamination processes.

The Sterilization Engineering and Sterilization Maintenance Validation organization plays a key role in governing the quality and GMP compliance relating to production processes for the site and Department Environmental Protection permit for decontamination of waste and equipment.

The organization is responsible for maintaining the requalification of sterilization and decontamination program for the site to meet regulatory and DEP permit requirements.

The requalification program ensures the equipment and processes for sterilization and decontamination maintains the validation status of the equipment. site.

Acronyms

o SE / SVM Sterilization Engineering, Sterilization Validation Maintenance

o CAPA Corrective Action Preventive Action

o CI Continuous Improvement

o SIP Steam In Place

o VHP Vaporous Hydrogen Peroxide

o PAA Peracetic acid

o AVS Advanced Validation System (Kaye Instruments)

o RT Real Time (Kaye Instruments)

o GMP Good Manufacturing Practices

o M&S Manufacturing and Supply

o SQT Steam Quality Testing (EN285)

o SME Subject Matter Expert

o SLA Service Level Agreement

o T&M Time and material

Scope Description

The SE / SVM organization is outsourcing the following scope / service.

SE / SVM execution and documentation support for non-routine changes to equipment and processes due to requalification, small capital projects, CAPA and CI.

The supplier will author SE / SVM deliverables for assigned projects based on input documents and collaboration with cross-functional teams.

Typical SE / SVM deliverables include : technical assessments, protocols, and summary reports. Technical Assessments can evaluation thermal assessments, heat penetration mapping, biological challenge studies, steam quality testing, P&ID assessments, and quality risk assessments.

The supplier will perform protocol execution and be highly knowledgeable using Kaye AVS / RT thermal systems, biological indicators, steam quality testing apparatus, and VHP gas testing apparatus.

The supplier will be able to setup analyze thermal and biological data for sterilization / decontamination autoclaves, depryogenation tunnels, dry heat ovens, SIP cycles, depryogenation tunnels, and VHP / Peracetic acid isolators with limited direct supervision by SME.

The supplier will perform document workflows for new and revised SE / SVM program and project-related documents with input from

management and SMEs.

The following is a sample of current projects within the scope of this Statement of Work.

o (10-15) small projects in Sterilization process investigation, optimization of new item addition of autoclave loads, for GMP / Decontamination autoclaves and process equipment changes in Buildings 46, 55, 56, 57, 59, 77 and 79.

o Performance Qualification of new load setup for QC ISOTest VHP system

o Thermal evaluation of depyrgenation tunnel load for 2mL vial technical transfer

o IOQ qualification of Kaye AVS / RT software upgrade include procedural updates

o SIP cycle heat penetration / biological challenge qualification of Line 8 filling line for piping and needle modifications

o Requalification including empty chamber mapping, heat penetration and biological challenge studies for 15 GMP autoclaves.

o Requalification including SIP cycle heat penetration and biological challenge studies for 10 production equipment systems.

o Requalification for 2 depryogenation tunnels, 7 VHP / PAA isolators, 3 depryogenation ovens, 6 SQT, 1 Lyophilizer temperature mapping, 1 dry heat penetration / biological challenge.

o Requalification including heat penetration and biological challenge for 24 decontamination autoclaves.

The supplier will manage the activities of their staff and will provide detailed tracking and reporting related to staffing, budget, project assignments and issues.

Supplier will provide experience support skills in sterilization engineering, autoclave qualification, VHP qualification, dry heat depyrogenation qualification.

Supplier will have 3-5 years knowledge, expertise, and training in FDA, EMA, EN285 and Annex 1 regulations for moist heat, VHP, and dry heat sterilization validation requirements.