Job Summary:
Establishes specific expectations and objectives to ensure compliance with EHS guidelines,cGMP regulations, company policies, and other external agency regulations.Supports the development of related procedures and programs, implements and monitors performance , identifies areas of opportunity, and prepares specific action plans to increase awareness and maintain compliance.
Work with the utility manager/team leader to complete design and engineering projects within the schedule, budget, and quality constraints.
Review of engineering specifications and drawings; review of Utilities engineering documents for equipment/systems such as instrument air, process air, special gases (oxygen, LPG, Nitrogen), RO, WFI, clean steam systems, and industrial steam.
Provide guidance and leadership to colleagues in technical aspects, thoroughness, and detail oriented to ensure fulfillment of plant/equipment operation and maintenance team.
Identify potential risks as and when and propose mitigation measures. Regularly escalate risks and proposed mitigations to the section and utility manager.
Job Responsibilities:
- Data analysis for utilities production and consumption trending preparation for higher management. Utility sections alarm trending and evaluation as per the SOPs.
- Utilities operating and production costing from JI to JX plants and consolidation with JI to JXII plants and WWTP.
- Responsible for plant consumables from JI to JX plants (PR creation, offer technical reviews, Follow-up, and section inventory).
- Coordination with the Julphar AutoCAD team for the updation and generation of plant layouts and P&lDs for the water system, compressed air systems, and gas systems from JI to JX plants.
- Ability to evaluate the technical complexity of the task/project and align materials, parts, tools, and skill sets to accomplish the task/project, prioritizing using resources to achieve business results.
- Preparing OJT questionnaires and coordinating with the coaches and staff to implement the training and update the necessary documents.
- Initialization and follow-up of CAPA, Deviation, and change control through the EQMS system as per the section's demand.
- Further duties include coordinating and managing utility shutdowns, planned system outages, and other operations impacting the manufacturing facility.
- Provides System Matter Expert (SME) input and approvals on deviations, change control requests, standard operating procedure revisions, action notices, and other quality systems.
- As a maintenance SME, the interfaces with engineering, validation, manufacturing technical support, system owners, and senior site leadership, to provide updates, project status, scheduling updates etc.
- Coordinate to complete all pending SAP notifications/orders/PR activities without delay.
- Commitment to a fair and respectful relationship with others and behavior in accordance with the company code of conduct
- Performs other related duties assigned by utility manager/team leader
Core competencies:
Training and Development:
- Experienced in preparing and reviewing standard operating procedures, on-the-job- training and other controlled documents
- Good organizational and technical writing skills
Managing Performance
- A team player with good co-workers and stakeholder management and good interpersonal skills.
- Strong equipment troubleshooting and root cause analysis skills
Team Building
- Ability to build and maintain collaborative relationships between teams, departments, and business units.
- Encouraging active participation and cooperation within the team
Commitment to Excellence
- Ability to organize prioritize work in the face of shifting demands and tight deadlines
- Active seeker for new ways of working to improve productivity.
Qualifications
- Diploma in Engineering.
- Eight years of technical experience in pharmaceutical industries and other manufacturing facilities.
- Strong technical and safety knowledge and experience in utilities engineering.
- Experience working for a maintenance organization in a cGMP Biotech/Pharmaceutical manufacturing environment
- Good organizational and technical writing skills
- Excellent in speaking, reading, writing, and understanding of English language
- Excellent computer knowledge of EQMS, EDMS & ERP systems.
