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<pre>Array ( [var] => cut_url ) </pre> Resume for Rory C. for Engineer / Biotechnology & Pharmaceuticals in Cork, Ireland. Search More Resumes for Engineer on Resumark.com #I7VH25LRN
 

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Resume for Rory C. for Engineer / Biotechnology & Pharmaceuticals in Cork, Ireland




Occupation: Engineer Industry: Biotechnology & Pharmaceuticals
Country: Ireland City: Cork
State: Cork ZIP: n/a



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roryC.seniorengineer

validation / pharmaceuticals 

e:    m: +    skype id: rory.C.    
 

careersummary  

A qualified and competent Senior Validation Engineer, having over years’ experience gained predominantly in the pharmaceutical sector. I have gained extensive experience in facilities validation, HVAC & utilities validation/commissioning, process validation, vendor auditing, USP purified water validation, biologics validation and S/S based computer systems validation. I take pride in my Six Sigma, risk assessment, design qualification and project engineering/management skills.  I am now seeking a suitable opportunity in Australia.  

keyskills  
 
  • Pharmaceutical API validation
  • Secondary pharma equipment / process / packaging validation
  • Computerised systems validation
  • Project engineering and management
  • HVAC commissioning and qualification
  • Retrospective quality systems remediation / development
  • Validation life cycle remediation / development
  • Biopharmaceutical design commissioning and qualification
  • USP purified water systems validation
  • Black, grey and white utilities commissioning and qualification
  • Laboratory equipment validation
  • Technical writing and documenting skills
  • Supporter of lean Initiatives at vendor / supplier sites
  • Budgeting, scheduling and management of crossfunctional site teams
  • Affable, even tempered and polite
  • Ability to deliver under pressure and multitask
  • keyqualifications  M.SC. ENVIRONMENTAL ANALYTICAL CHEMISTRY UNIVERSITY COLLEGE CORK, IRELAND  B.SC HONS GEOLOGY UNIVERSITY COLLEGE CORK, IRELAND keytrainings  LEAN SIX SIGMA FOR DESIGN GREEN BELT

          AVETA BUSINESS INSTITUTE 

    keyaffiliations CURRENT INSTITUTE OF ENGINEERS OF IRELAND

    MEMBER MIEI 

    computingskills
  • S and S Automation Systems Methodologies Advanced
  • CFR Part Regulations Advanced
  • GAMP Advanced
  • Microsoft Word, Excel, Project, Outlook – Advanced
  • MindGenius Advanced
  • Microsoft PowerPoint, Visio Intermediate
  • Agile Intermediate
  • Microsoft Access Basic
  • SAP Basic
  •  
     
     
     

    roryC.seniorengineer

    validation / pharmaceuticals 
     

    employmenthistory SEP CURRENT SUPPLIER QUALITY & SUPPLIER DEVELOPMENT ENGINEER

          Depuy Ireland Limited, Republic of Ireland

          

    Founded in , DePuy today is a $. billion global medical device manufacturer, serving patients worldwide and employing over , scientists and staff. Contracting through C. Scientific Ltd as a Project Manager on a supplier quality development project for cross linked polymer supply, I am responsible for improving quality and lean activities at existing supplier's sites and setting up another parallel supplier with a complete quality and approved validation life cycle system. Reporting to the International Supplier Quality Manager, I manage a cross functional team. 

    Responsibilities:

  • Manage the Polymer Supplier Quality Improvement and Process Leaning project
  • Quality Drive the supplier capacity and quality improvements for purchased products by increasing supplier and internal competencies in process control / verification and validation studies, root cause analysis, failure mode and effects analysis FMEA, and the use of Process Excellence tools
  • Vendor Development Interface with the new product development groups to assist and lead the supply chain related capacity and logistics initiatives along with the associated supplier quality engineering activities in developing and reviewing product design and test protocols
  • Project Management Manage a cross functional team of R&D, purchase, quality, new product introduction and lean professionals
  • Project Engineering Provide general engineering support to incoming inspection on specific projects
  •  

    ACHIEVEMENTS:

  • Have successfully managed the cross functional project team to deliver project on time and within budget with all quality and lean objectives achieved
  • JUN JUN  SENIOR ENGINEER AUTOMATION VALIDATION

          M+W Group, Peoples Republic of China

          ,

    Wyeth, acquired by Pfizer in , had appointed the PM Group and M+W Group to provide full design, project and construction management services for the development of a new worldscale greenfield infant nutritional facility in Suzhou, China. As a Senior Automation Validation Lead of the M+W group, I reported to the Automation Project Manager and championed the automation validation activities for a team of automation engineers who were responsible for installation, commissioning and qualification of Pfizer site production control systems, building management and environmental monitoring systems. 

    Responsibilities:

          Nutrition Validation

  • Design / commission / qualification of Pfizer Site Nutritional Process Automation Systems to S / S and Gamp standards
  • Site nutritional process systems included:
  • Warehouse Management System WMS
  • Raw materials handling and tracking
  • Vitamin/mineral dispensary system WS
  • Wet process and compounding equipment
  • Evaporators and UHT
  • Valve matrix and dryers
  • Finished powder handling and tracking
  • Package line filling system and CIP/SIP systems
  •  

          PLC/SCADA

  • Witness integrated Factory Acceptance Tests FAT
  • Commissioning, qualification and integration of vendor PLC/SCADA systems with Rockwell / Allen Bradley batch interface
  • Peertopeer communication with other PLCs on phase level
  •  
     

    roryC.seniorengineer

    validation / pharmaceuticals 
     
     

          BAS/EMS Validation

  • Design / commissioning / qualification of Siemens APOGEE Building Automation System BAS and Environmental Monitoring System EMS
  • Witness, review and pre / post approval of process automation systems' User Requirement Specifications URS
  • Validation Master Plan VMP and Individual Validation Plans IVP
  • Functional Design Specifications FDS, Hardware Design Specifications HDS, Software Design Specifications SDS, Design Qualifications DQ
  • FAT, Site Acceptance Tests SAT, Risk Assessments RA, Gap Analysis GA
  • Installation Qualifications IQ, Operational Qualifications OQ, Performance Qualifications PQ, deviations/CR and Final Reports where appropriate
  •  

          Vendor Supervision

  • Management and supervision of specialist equipment vendors
  •  

    S / S based Computer Systems Validation

  • Support qualification of recipe level and enterprise level systems such as Batch Historian, Electronic Batch Record, EBR, SAP, and material tracking systems according to S / S principles
  •  

    ACHIEVEMENTS:

  • Successfully accomplished the commissioning and qualification of Pfizer site production control systems and of environmental monitoring and control systems
  • AUG APR  VALIDATION SPECIALIST

          Pfizer Ireland Ltd, Republic of Ireland

          

    Established in , Pfizer is one of Ireland's leading pharmaceutical companies, employing , people across locations in Ireland. Contracting through C. Scientific Ltd, I was responsible for providing site validation support to the project engineering department, maintaining the site validation systems in compliance, being the Validation Engineering SME at audits and rolling out new corporate validation initiatives to the site. I was a key member of a team of validation engineers who managed all site project engineering validation activities and reported to the Engineering Director. 

    Responsibilities:

  • Ownership of Pfizer Ireland ltd Loughbeg API site commissioning and qualification procedures
  • Implementation of system and component impact Systems and rollout for site
  • Ensuring consistency in validation approach across Pfizer Ireland sites
  • Project engineering validation support to QA, production and project engineering departments
  • Authoring, review and approval of change control, design, commissioning and qualification documentation for equipment, utilities, HVAC process and purified water
  • Project engineering validation including support for new single thermal fluid reactor heating / cooling system, utility pace setters for dosing water chemicals, qualification of new reactor charge chutes, charge booths etc.
  • Support site automation team and site production to ensure PQ of recipes for CB building DCS batch upgrade
  • Review and approval of site automation change control forms, CSV protocols and SOPs
  • Management of the periodic review programme for site process systems and equipment
  • Participation in Six Sigma Rig

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