Provide hands-on technical support for plant utility and process systems and participate in developing relevant maintenance information on our clients CMMS (SAP) (equipment records, Functional Locations, task lists, BOMs). Provide hands-on technical support for set-up and operation of manufacturing process systems from commissioning through qualification and into commercial manufacturing. Assist in the development of operational procedures and work instructions. Coordinate and supervise the activities of external vendors for supporting process and utility systems. Follow relevant Lock Out Tag Out (LOTO) procedures in carrying out maintenance activities. Work under minimal supervision to create maintenance task lists and associated Energy Control Procedures. Assist in the implementation of the site CMMS (SAP) through the development of relevant maintenance documentation. Develop relevant engineering documentation, including but not limited to Standard Operating Procedures (SOP) and Standard Work Instructions (SWI). Work collaboratively with project stakeholders and system owners to review C&Q information and ensure operation and maintenance requirements are identified in line with our client's policies and procedures. Gather, analyse and amalgamate technical information from various sources to assist in maintenance task list development and spare parts identification. Ensure Good Documentation Practices (GDocP) and GMP compliance in the review and approval of relevant system and project information. Complete spare parts analyses and determine optimum stocking strategy. Assist our Client's Project Manager and the ESS Lead Technician in tracking and reporting progress, and proactively escalate potential issues for resolution. Participate in cross functional team meetings (operations, engineering, quality etc.). Support in the identification and procurement of necessary equipment and tools required to complete identified operational and maintenance activities. Populate CMMS control form templates to upload relevant maintenance and calibration information. Work with engineers and project managers to ensure that technical information contained in operational procedures and maintenance task lists is accurate and reflective of data provided for equipment qualification. Specific duties when plant commences operations: Day to day operation, repair and maintenance of all utilities and process systems necessary to support manufacturing and to ensure the safe and efficient operation of all systems. Work with Manufacturing, Quality and outside vendors to complete servicing, calibration and validation work on equipment and utilities. Assist with the validation and requalification of GMP systems. Draft and implement LOTO permits. Assist in the calibration of instrumentation on plant equipment and utilities and preparation of SOP's for all items. Proactively inform CMMS administrator of any updates to the Master Equipment List (MEL) and the Master Instrument List (MIL) for the site and ensure all calibration standards are suitable for use and certified. Guide and assist external service contractors on site (i.e. permits, supervision, access control, etc). Participate in Engineering Department on cross-functional projects and daily support of process development and manufacturing as required. Support site upgrades or improvement projects as required throughout the facility. Adhere to safe working practices as set out in the safety statement and other safety instructions. Assist in providing a safe place of work. Education / Work Experience: Minimum of 3 years' hands on experience in pharmaceutical/medical device industry. Degree/Diploma/Apprenticeship in a relevant engineering discipline is a distinct advantage. Knowledge and experience of Good Manufacturing Practices (GMP). Experience developing maintenance task lists and identifying spare parts requirements. Ability to interpret P&ID, HVAC, utility schematics and electrical drawings. Proficient in Microsoft Office (Excel, Word, PowerPoint). Knowledge of SAP PM Module is advantageous. Excellent communication skills. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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