Role Summary
An Equipment Maintenance Engineer is responsible for ensuring the optimal performance, reliability, and safety of machinery and equipment used in pharmaceutical industry. This role involves planning and executing preventive and corrective maintenance, troubleshooting equipment issues, and implementing improvements to reduce downtime and extend equipment life.
Role Responsibilities
Overall Functional responsibilities
- Understand & Practice relevant EHS requirements, including EHS guidelines and can refer to the procedure for the correct information when not clear.
- Identify safety improvements.
- Can initiate General and LOTO permits.
- In-depth knowledge of specific engineering practices relevant to their field. Understanding of regulatory standards and quality control measures.
- Competence in applying standard engineering practices and procedures under supervision.
- Ability to perform routine tasks with some guidance.
- Knowledge of EAMS functionalities, including preventive maintenance scheduling and work order management.
- Initiate EAMS work order and execution independently.
- Comprehensive knowledge of equipment qualification standards and regulatory requirements.
- Ability to conduct equipment qualification tests and document results accurately.
- Can troubleshoot basic issues with guidance.
- In-depth understanding of inventory management principles.
- Knowledge of basic forecasting methods.
- Familiarity with inventory management software and tools.
- Ability to conduct stock counts and inventory audits.
- Managing reorder points and lead times
- Using software to track spare parts inventory
- Understand equipment working principle, and equipment manual
- Understand basic mechanical or electrical knowledge for equipment maintenance
- Equipment verification knowledge
- When find equipment error or hidden danger, stop it, can analyze, and determine simple faults and make partial adjustments
- Able to use professional tools like multi-meter, analyzer.
- Able to determine errors within operating area and outside the control cabinet.
- Able to carry out mechanical and electrical maintenance.
- Able to train operators in simple troubleshooting.
- Coordinate to manage consumables and spares required by own shift, check storage level.
- Coordinate to make maintenance plan for spares of own shift and execute the plan.
- Participate in equipment improvement project.
- With guidance from equipment suppliers and experienced engineers, conduct more comprehensive preventive maintenance beyond cleaning and lubricating.
- Repost, conclude and paraphrase the learning.
- Check and correct the work of others.
- Participate in deviation investigation, support problem solving.
- Execute per CAPA requirements.
- Able to follow relevant compliance requirements.
- Comply to relevant compliance procedures
- Correct self and others when finding noncompliant behaviors.
- Identify potential noncompliance in relevant areas and participate in improvement activities.
- Provide improvement suggestions and participate in implementation.
- Fill in the required records correctly and independently.
- Review and correct other’s records.
- Understand relevant audit requirements and prepare for them accordingly.
- Independently answer questions relevant to your own work correctly and provide proper evidence.
- Take main role in some compliance improvement work
- Understand relevant equipment operating SOP/WI/ cleaning / lubricating knowledge.
- Understand the functioning of equipment parameters.
- Aware of overall process and regulations about new equipment, and new process introduction.
- Revise or write relevant SOP/WI.
- Understand M1 method and tools.
- Understand the equivalent knowledge of yellow belt.
- Understand basic lean production knowledge (8 waste, 5S, visual management, standard work, continuous improvement, PDCA circle, etc.).
- Coordinate with others to use M1 to improve quality deviations, safety incidents, equipment performance, explore the root causes and implement effective measures.
- Make standard for 5S, visualization and standard work, coach relevant person to implement.
- Able to follow PDCA cycle for problem solving and improvement projects.
- Take the initiative to share with others about learning outcomes.
Technical Responsibilities
- Perform routine and preventive maintenance on Upstream & Downstream areas: Solution Preparation, Fill Finish Lines Sterilization, Visual Inspection, Packaging and Microbiology equipment.
- Troubleshooting of minor technical issues & learning to handle Major technical issues: Fill Finish Lines, Solution preparation, Sterilization, Visual Inspection, Packaging and Microbiology equipment.
- Collaborate with operations and engineering teams to improve system reliability and performance.
- Ensure compliance with safety standards, industry regulations, and quality protocols.
- Assist in the installation and commissioning of new equipment Includes Mechanical & Instrumentation systems.
- Participate in audits and inspections, providing technical support and documentation as needed.
- Support equipment qualification and validation processes (IQ/OQ/PQ).
- Execution of spare parts & Inventory.
- Calibrate instruments such as pressure gauges, temperature sensors, flow meters, and analytical instruments.
- Work with PLCs, SCADA, and Microbiology systems used in pharmaceutical manufacturing.
- Supporting automation projects and upgrades.
- Knowledge of control system wirings, P&ID drawings.
Behavioral attributes
- Communicate clearly and effectively in both written and verbal formats, actively listen to others, and maintain professional interactions with colleagues.
- Collaborates effectively across teams, builds positive working relationships, demonstrates flexibility in dynamic environments, and respects cultural differences.
- Organizes daily work effectively, balances priorities with minimal supervision, takes responsibility for outcomes, and responds promptly to urgent situations.
- Proactively drives personal development and supports the learning of others, leveraging knowledge to improve team performance and operational outcomes.
- Proactively addresses challenging or sensitive issues, including raising concerns about non-compliance or inefficiencies. Encourages others to speak up.
- Consistently identifies opportunities for process improvements and suggests practical, forward-thinking solutions.
- Make timely and effective decisions in familiar situations, taking ownership for outcomes while ensuring compliance and safety.
- Actively seeks input from all team members, values diverse perspectives, and promotes collaboration to achieve shared goals.
- Upholds and advocates for high ethical standards, ensuring others also act with integrity while promoting a culture of trust and accountability.
- Prioritizes key tasks effectively, understands and communicates roles within the team, and tracks outcomes to ensure quality and timely results.
- Recognizes and celebrates the achievements of others, shows pride in their role and team contributions, and promotes a positive and enjoyable work environment.
- Demonstrates a willingness to adapt to new challenges, respectfully engages in conversations, builds trust through consistent behavior, and shows basic empathy toward colleagues.
Essential Requirements
Preferred Education/ Qualification
Diploma or B. Tech in Equivalent to Mechanical or Instrumentation or Electronics Engineering.
Experience
B. Tech with 2 to 5 years industrial experience.
Core Competencies
- Basic understanding of Good Engineering Practices
- Foundational understanding of EHS & GMP requirements
- Basic expertise in Repair & Maintenance
- Knowledge of Equipment Qualification
- Foundational communication abilities
- Effective collaboration and team contribution
- Efficient task management and responsibility
Work Location Assignment: On Premise
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Engineering