Project Leader and Automation\CSV specialist – IRBM, Engineering Maintenance and Technical Services Unit – Ref. 180 B

October 19^th, 2022

Project Leader and Automation\CSV specialist – IRBM, Engineering Maintenance and Technical Services Unit – Ref. 180 B

IRBM is an innovative contract research organization working across all aspects of drug discovery and early development for different modalities – small molecules, peptides, RNAs and antibodies. We foster collaborations with organizations from the pharmaceutical, biotech and academic sectors to accelerate drug discovery from target validation and hit identification to candidate nomination. Our 200 plus-strong, multidisciplinary teamwork at a state-of-the-art R&D facility near Rome where projects are carried out “under one roof” enabling rapid cycle times and close integration of the scientific teams. IRBM’s scientists have discovered several drugs that are on the market, and more than 25 compounds have gone into clinical testing. The company was founded in 2010, as a spin-off from Merck & Co. Now in our 12th year as an independent research organization, we have laid the foundations to become a global center for excellence in all aspects of drug discovery and early development.

Job Description

IRBM is currently looking for a resource to be included in the Engineering, Maintenance and Technical Services Department. Under the direct coordination of the Unit Manager, he/she will be involved in the following activities:

• Support and promote automation program of the Site for non – GMP and GMP areas;
• Lead the migration of the existing BMS system (Schneider Electric) to new BMS platform (iFix), developing automation requirements, coordinating External Contractors and supervising commissioning, startup and qualification activities (GMP field);
• Design new control systems for HVAC, utilities (including Energy KPI), laboratories and pharmaceutical process;
• Support CSV activities for GMP systems working together with Qualification Department;
• Coordinate Site Capital projects and assist Unit Manager in the analysis of strategic growth of the Site;
• Work together with Scientific Equipment and IT Engineers to define HW and SW architecture for new equipment, supervising systems configuration during installation and startup;
• Contribute to maintenance program for automation and computerized systems;
• Maintain and upgrade engineering & maintenance documentation of the plants / Site (electrical drawings, software and hardware functional specifications, I\O list, instruments datasheet and spare parts etc.);

Key responsibilities:

• Prepare technical and user requirement specifications for assigned projects;
• Lead the design and the implementation of electric equipment, instrumentation and software, according with current regulations (electrical and safety) and international standards;
• Prepare and review project’s drawings and technical documentation, coordinating External Suppliers;
• Select proper electric equipment, software and hardware and define installation procedures;
• Supervise the project’s execution activities, coordinating Contractors and external resources;
• Supervise CSV activities package for GMP application (URS, FS, SDS, HDS, SAT, IQ, OQ, PQ etc.)
• Issue project’s plan, monitor costs and changes, manage assigned budget and issue periodical projects report;
• Review and archive engineering documentation;
• Guarantee maintenance handover;
• Write and update SOP (automation and CSV);
• Support the implementation on BMS of metering and reporting system for Energy program.

Competencies and skills:

• Ability in the interpretation / understanding of wiring diagram (electric and electronics schemes);
• Good knowledge of PLC systems (Siemens) and SCADA (iFix);
• Good knowledge of PC (in terms of both software / hardware);
• Good knowledge of GMP/GAMP;
• Good knowledge of the major current regulations (electrical and safety) concerning electrical equipment safety aspects;
• Project management;
• Organizational skills to manage multiple projects and tasks, with attention to details;
• Problem solving;
• Flexibility and adaptability features;
• Results-driven personality with high level of enthusiasm, energy and confidence;
• Proactive approach and team building spirit;
• Strong interpersonal skills;

Qualifications:

• Engineering degree (automation, electrical, electronic or mechatronic);
• Minimum experience of 5 – 8 years in automation and complex projects management;
• Minimum experience of 5 years in pharmaceutical area;
• Advanced knowledge of the main applications of the MS Office™
• Basic knowledge of Autocad;
• Good knowledge (written and spoken) of the English language.