Production Engineer

About the role

We are looking for an experienced Production Engineer with a solid background in biopharmaceutical manufacturing. The ideal candidate is skilled in process validation, cGMP compliance, and continuous improvement within a regulated production environment.

Responsibilities

• Provide technical leadership for production systems, ensuring compliance with SOPs and regulatory standards.
• Manage and revise SOPs, Batch Records, and related compliance documentation.
• Investigate non-conformances; lead CAPA and effectiveness check processes.
• Perform periodic revalidation of batch records, utilities, and cleaning validation.
• Initiate and manage Change Requests for continuous process improvements.
• Oversee production scheduling, workforce planning, and shift operations.
• Support IQ/OQ/PQ and requalification activities for critical equipment.
• Act as SME during regulatory audits and support audit-readiness activities.
• Lead Kaizen and Lean initiatives to drive productivity, quality, and safety improvements.
• Collaborate with QA, QC, Microbiology, and Engineering teams for production and compliance goals.

Requirements

• Degree/ITE/Diploma in Biotechnology, Life Sciences, or a related discipline
• Experience in aseptic processing, CIP/SIP, and cleanroom operations
• Proficiency in DCS systems and equipment commissioning
• Familiar with global regulatory audit requirements
• Proven shift team leadership and cross-functional collaboration
• We appreciate your interest in joining our team. Only candidates shortlisted for interview will be notified

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Company Intel

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