Automation Engineer

Role & responsibilities

1. Key Accountabilities

Major Activities / Tasks

I. [E] Implement & Maintain Interdependent

Safety Culture [ This is a multidisciplinary line job and hence safety takes priority]

• Implement and Maintain a safety culture with zero reportable and LTA (Loss Time Accident)
• Ensure that any change to Plant automation system is only done after the due approval for Plant Automation Modification Authorization / Change Control. An implementation factors the recommendations from the Risk Assessment document for the change authorization.
• Report all near incidents, data losses, errors related to automation system. Participate in Investigations as required. Communicate across shift operations. Implement CAPA as required.
• Conduct WPI, BOS Tours, Internal audit of ME EHS Standards and implement CAP for effective EHS on Shop Floor.
• Ensure statutory compliance inspection of control system and documentation are carried out as per approved checklist and documented.
• Check all safety interlocks of Critical Machines are checked as per sop and relevant standards
• Implementation of Automation projects in operations Function. GEP, cGMP, and statutory requirement are to be duly incorporated.
• Ensure updated DEPs are suitably implemented.
• Harmonize Automation practices at site. Ensure best practice guidelines are suitably implemented by all site projects.
• Ensure updated Automation strategies are suitably implemented.
• Ensure the implementation of condition-based monitoring, predictive and preventive maintenance are duly incorporated in the Maintenance and Integrity strategies.
• Review each equipment against the Critical Not Critical Category
• Categorisation of equipment with respect Compliant/ Non-compliant in alignment with CQA.
• Discussion and methodology to be worked out with Automation Vendors and OEMs for the Compliance requirement.
• Budget preparation and alignment
• Budget presentation to cross functional leaders for their alignment and approval.
• Phase out plan to be prepared with Roadmap and blueprinting for the project.
• IT infrastructure requirement to be worked out for New Servers and Networking components.
• Technical Support to CQA & Site Validation team to execute the project.
• Manage and Track existing SCADA and DCS project.
• Co-ordination with Automation Vendor to enhance the application with new features and additional requirements, if any.
• Co-ordination with Automation Vendor and Central IT for Infrastructure setup, Enterprise Architecture and Cyber Security.

II. [E]cGMP

• Ensure that Automation system complies with cGMP norms & GEP during maintenance execution.
• Plan, execute and submit to QA compliances related to regulatory audits
• Address non-conformances of Automation system through deviations and implement the CAPA to maintain quality score matrix
• Keep the Automation system upgraded as per latest technology and complying to current GMP requirements
• Write / Review / Evaluate change controls related to system and document and study of impact related to changes and to ensure implementation of change.
• Initiate / Review major deviations as per standard procedure and necessary CAPA in relation to deviation.
• Blueprinting of automation level at site.
• Maintain the Enterprise Level architecture for Automation projects and Advanced analytics digital use cases.

III. [E]Maintenance Execution:

• Assess and handle instrumentation and Automaton breakdown maintenance to avoid recurrence and maintain continuous process operations by maintaining critical parts availability and adherence to PPM schedule; ensure that hand back the Asset under maintenance is done with due compliance to Cipla Policies, Standards & Procedures. Identify any essential Asset replacements / retirals
• Attend and review breakdown, scheduled work and its completion to minimise impact on quality and production
• Check that critical Instrumentation and control system spares inventory of all machines are maintained to reduce resolution time
• Follow PPM as per schedule to avoid breakdown
• Procure, inspect and approve material from engineering store
• Comply with Instrumentation and Automation maintenance execution work processes
• Ensure the proper, timely and safe implementation of preventive and corrective maintenance activities
• Ensure critical Instrumentation & Automation spares of critical m/c are maintained to reduce resolution time by predicting demand and reviewing availability
• Instrumentation Maintenance execution is documented as per the Cipla Global Standards & Procedures.
• Drive proactive Condition Monitoring program for Unit Operations
• Implement digital transformation roadmap for the site
• Ensure appropriate IT infrastructure is cultivated and deployed at the premises.
• URS to be prepared with the specific requirements as per the QMS policy.
• Implement new technology in Utility Management system, Energy Monitoring, Predictive maintenance and Water management system.

Manage and Implement Automation projects (SCADA, DCS, Incrency, eTrack & Data Tech)

• Alignment to the Company Vision, Mission, strategy and objectives on digitization in Operations.
• Project delivery to Cost, Quality and Schedule.
• Meeting Business Plan targets: deployment and budget utilization
• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant DCS and BMS systems, data concentration, batch reporting, and data retention.
• Support 24x7 site-based operations after startup.
• Prepare scopes of work and lead automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Determine equipment or system specifications and most cost-effective technology to be implemented.
• Participate in discussions with internal business partners on priorities and timelines, consistently supporting the transparent sharing of information.
• Develop equipment specifications in standard documentation User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Participate in operational excellence and continuous improvement efforts.
• Problem solve any technically related issues impacting production.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform with standards and policies.

2. Major Challenges

• CapEx and OpEx Adherence to the budget
• Cost vs performance trade off in Automation system
• Ageing Asset leading to escalating OpEx Cost
• Challenges around capability & competence of personnel and service providers
• Key backbone and interface between the users, IT team, Quality, Procurement and vendors.
• Regulated and Automation Guidelines adherence.

3. Key Interactions

Internal

• Central Engineering for technical standards and guidance
• Finance for Capex & Opex proposal approvals, analytics & MIS
• EHS for safe operations and near-misses
• HR for Attrition, Recruitment, Training
• Site head & Unit heads for Proposals, breakdowns and developments
• Engineering DR for Guidance & Updates
• Indirect purchase for Spares, scope, insurance and new vendors
• Central purchase for provide Technical inputs and clarifications for CAPEX
• Global Leadership Team Guidance & Updates in TLT, Focus Calls & Reviews
• Corporate Affairs & Legal Team Guidance & Updates on Compliance matter

External

• OEMs for projects, automations, alternate vendor development , quality issues and maintenance •
• Facility maintenance contractors for Improve maintenance and quality standards
• Industry Bodies Connect on external benchmarking & information on technology evolution
• Statutory Bodies Connect for Regulatory compliance

Preferred candidate profile

BE/BTech Instrumentation degree with at least 10-15 year of experience in Engineering roles preferably in Pharma Industry.

Ability to implement new techniques, development of automation practices (DCS, SCADA, MES, UMS) deep understanding of Automation projects, Analytics, planning and organizational skills, prioritization multi-tasking, understanding of financial concepts like CAPEX, OPEX etc., knowledge of CSV guidelines.

Advance knowledge in following is recommended:

• Siemens PLC/ Step 7
• Siemens PCS7/ Step7/ WinCC/ Batch/ Route Control
• OSI PI system and architecture
• inmation
• Wonderware, Schneider Electric
• Hardware configuration and software coding
• Knowledge of FDA regulations, particularly 21 CFR part 11, FAT, IQ, OQ, PQ and Life Cycle management of computerized system and GMP systems
• IT knowledge for Server/Client and Infrastructure

Electrical, instrumentations and control knowledge

Recruiter Details

Mohaneswara Reddy

https://www.linkedin.com/in/mohaneswarareddy