Pharmaceutical jobs in United States

Job Title: Pharmaceutical Engineer

Location: Ipoh Perak

Department: Production / Manufacturing (OSD)

Role Summary:

The Pharmaceutical Engineer will provide strategic leadership and operational oversight for the Chemor Production Facility, with a focus on oral solid dosage (OSD) manufacturing. The role ensures full compliance with cGMP, efficient achievement of production targets, and ongoing enhancement of manufacturing processes to support zero-defect operations and regulatory readiness (EU/FDA). This role demands technical expertise in granulation and tableting, team leadership, and a strong commitment to quality and continuous improvement.

• Ensure full compliance with current Good Manufacturing Practices (cGMP), SOPs, and regulatory requirements (EU, FDA, etc.).
• Enforce zero-defect policies, fostering a strong quality culture throughout the production team.
• Maintain documentation accuracy, including BMRs, BPRs, logbooks, and inventory records, ensuring audit readiness at all times.

• Lead and manage daily manufacturing operations to meet production targets and quality standards.
• Plan and execute plant-specific projects from concept to completion, ensuring timelines, resources, and deliverables are met.
• Manage raw material availability aligned with production needs to prevent shortages or overstock.
• Control production yields, analyze variances, and drive continuous improvement to minimize waste and inefficiencies.

• Ensure all plant equipment operates within validated parameters and optimal performance levels.
• Supervise machine setup, operation, part changes, and basic maintenance to prevent breakdowns and ensure uninterrupted production.
• Perform root cause analysis for process or equipment-related deviations and implement corrective/preventive actions (CAPA).
• Generate reports on equipment health, preventive maintenance, and production efficiency.

• Operate, monitor, and troubleshoot HMI systems for granulation and tableting machines (FETTE, O’Hara, Sensum, etc.).
• Set up, calibrate, and clean equipment in accordance with SOPs.
• Adjust machine parameters, handle alarms, and resolve product quality or mechanical issues.
• Ensure all production areas are clean, organized, and compliant with GMP standards.

• Supervise production teams to meet expected performance levels and maintain compliance with SOPs and GMP standards.
• Communicate effectively across shifts, ensuring clear reporting and handover of concerns.
• Promote a culture of safety, hygiene, and discipline on the production floor.

• Apply knowledge from on-the-job training and SOPs to improve processes and performance.
• Perform additional responsibilities as assigned by management.

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemical Engineering, or related field.
• Minimum 7 years of experience in pharmaceutical manufacturing, preferably in OSD (granulation & tableting).
• Experience in handling regulatory audits (EU, FDA) and documentation for GMP compliance.

• Strong working knowledge of cGMP, QMS, and pharmaceutical manufacturing operations.
• Proficient in Microsoft Office applications; experience with manufacturing systems and HMIs preferred.
• Skilled in authoring SOPs, BMRs, and other operational documents.

• Strong leadership and team management abilities.
• Excellent problem-solving and troubleshooting skills.
• Effective communication (written & verbal) and interpersonal skills.
• High level of self-discipline, attention to detail, and ability to multitask in a fast-paced environment.