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Asset Manager

Currently I am looking for an Asset Manager for a pharmaceutical company in Oss.

Job purpose:
* Optimization of the performance and reliability of the assets within the IPT
* Initiate and enable improvements for the IPT/CoE
* Maintain asset related documents (e.g. qualification documentation) up-to-date and compliant to GMP & EHS requirements

Products/Results
(Re)qualification/revalidation
* Responsible for maintaining qualification status of highly complex automated process equipment, installations and utilities of the IPT.
* Draft qualification protocols and ensure execution of the qualification in close cooperation with maintenance and bioprocess technicians.
* Draft qualification documents for installation changes and ensure appropriate change control
* Report and ensure approval of documents
* Collect calibration, corrective- and preventive maintenance data in order to revalidate asset.
* Ensure data in OIS and documentation is up-to-date

Asset support
* Collect monitoring data and perform trending
* Write monitoring reports (e.g. REM)) for the IPT and ensure execution of the monitoring make recommendations for improvement
* Train and instruct IPT personnel by the execution of asset support related activities, develop standardized work in cooperation with improvement lead and operations lead

New or improved manufacturing processes
* IPT/CoE representative in project teams for process transfers
* Write or review user requirement documents for assets
* Write or review qualification documents for installation changes

Continuous improvement (Capex projects)
* Write or review problem solving or proposal A3's for IPT/CoE related processes to improve performance (compliance, financial, robustness) of complex (automated) assets
* Write approval documents / business cases for CapEx projects
* Lead Capex and other improvement projects for the IPT
* Develop standardized work for manufacturing to drive out variation
* Train and instruct IPT personnel when implementing new or modified processes in the IPT
* Write or modify SOP's/ WI's for the IPT

Change control
* Change owner in GCM for technical changes
* Application management production critical systems (like PCS)

Deviation control/ Problem Solving
* Asses asset related deviations applying problem solving tools and Root Cause analysis
* Act as team leader in RCA
* Initiate or take necessary actions to follow-up on deviations (Tier 2 action responsibility)
* Propose corrective and preventive actions
* Enter relevant information in the deviation control system (Quest)

Tier processes
* Participate in the Tier process of the Maintenance and Reliability group
* Replace Maintenance and Reliability Lead during absence in Tier 4
* Develop visuals and maintain KPI's for the Tier boards

GMP, EHS
* Participate as engineer in (site) projects to improve EHS or GMP practices
* SME in safety studies for hazardous processes in the IPT/ CoE
* Comply with GMP and EHS requirements
* Participate in (external) audits or inspections
* Monitor RAM and CE status of systems

Competencies and experience
* Engineer at HBO+/academic level with at least 3 years of relevant experience in (bio)chemical manufacturing under GMP
* Proven ability to manage projects
* Certified MPS Greenbelt
* Passion for Lean and continuous improvement
* Excellent communication in Dutch and English

Are you interested in this position? Please apply online or get in touch with the consultant: Niek van Alfen, n.vanalfen[at]realstaffing.com / 020 522 15 88.