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An established industry player in the pharmaceutical sector is seeking a Maintenance Engineer to ensure the reliability and efficiency of manufacturing equipment. This role involves preventive and corrective maintenance, regulatory compliance, and continuous improvement initiatives. Join a dynamic team dedicated to innovation and excellence, where your expertise will drive significant enhancements in production efficiency and safety standards. This is an exciting opportunity to make a meaningful impact in a growing company committed to sustainability and quality in healthcare.
About
We are a pan-Asian pharmaceutical brand with a longstanding history in the market, having been selling across Asia for decades. Our medicine is the bestselling in its category thanks to its efficacy and strong brand recognition. As we expand our operations in Singapore, we are dedicated to innovation, sustainability, and excellence in every aspect of our business. Join our team to make a significant impact in the pharmaceutical industry during this exciting phase of growth.
The Maintenance Engineer is responsible for the reliability and efficiency of Oral Solid Dosage (OSD) manufacturing equipment. The Incumbent will handle preventive and corrective maintenance, troubleshooting, and optimization of key equipment like tablet presses and granulators. The role also includes managing in-house contractors to ensure compliance with GMP, ISO, and safety standards while minimizing downtime and improving production efficiency. Additionally, assist with utility design review, factory acceptance tests (FAT), commissioning, and qualification during project phases.
Key Responsibilities:
1. Equipment Maintenance & Reliability:
Perform preventive, predictive, and corrective maintenance on OSD manufacturing equipment (e.g., tablet presses, granulators, dryers).
Develop and execute maintenance schedules to maximize equipment uptime and performance.
Manage in-house contractors for troubleshooting and repairs, ensuring efficiency and regulatory compliance.
Maintain critical spare parts inventory and coordinate with vendors for procurement.
Conduct root cause analysis (RCA) and implement corrective actions to prevent recurring failures.
Optimize maintenance practices to reduce downtime and improve OEE.
2. Regulatory Compliance & Documentation:
Ensure maintenance activities comply with GMP, FDA, ISO, and safety regulations.
Maintain accurate maintenance records, SOPs, and validation reports for audits and inspections.
Support regulatory audits with documentation and technical explanations.
Develop and update maintenance SOPs to align with industry best practices.
3. Continuous Improvement & Process Optimization:
Identify and implement improvements to enhance equipment reliability and reduce downtime.
Collaborate with production, quality, and engineering teams to optimize manufacturing processes.
Participate in equipment qualification, commissioning, and validation activities.
Utilize maintenance data analytics to track trends and improve strategies.
4. Safety & Compliance:
Ensure maintenance activities adhere to safety, GMP, and environmental regulations.
Conduct risk assessments and implement preventive safety measures.
Train and mentor in-house contractors on equipment operations, troubleshooting, and compliance.
5. Project Phase Deliverables:
Review equipment specifications, layout drawings, and design documents.
Ensure timely completion of equipment selection and technical evaluations.
Participate in equipment design reviews and provide constructability feedback.
Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
Assist in commissioning, qualification (IQ/OQ), and production readiness.
Qualifications & Skills
Diploma or bachelor’s degree in in Mechanical Engineering, Electrical Engineering, or related field.
At least 8 years in calibration within pharmaceutical/OSD manufacturing; experience in commissioning/validating equipment; CRE certification is a plus.
Proficient in GMP, PIC/S, RCA, FMEA, lean maintenance, TPM, and predictive maintenance.
Minimize downtime through efficient troubleshooting and repairs; drive continuous improvements.
Workplace safety, hazardous material handling, and OSD system-specific training.
Strong understanding of mechanical, electrical systems, automation, and CMMS
Excellent analytical, troubleshooting, problem-solving, communication, and documentation skills.
Able to work in a controlled cleanroom environment, with the ability to lift moderate weights and handle on-call or shift work.
What We Offer:
Competitive salary and benefits package.
Opportunities for professional development and advancement.
A dynamic and collaborative work environment.