Padmi

Site Engineering Head / Cluster Head Engineering (sterile Formulations)

IndiaPosted 3 months ago
Engineering ManagementStaff+Full Time; Regular
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In this role at the Top 10 Pharma company in India, you will be responsible for overseeing engineering operations for sterile formulations manufacturing. Whether at a single site or across multiple sites cluster, your role will be critical in ensuring uninterrupted production, compliance with global standards, and continuous improvement of engineering systems. Key Responsibilities: - Lead engineering operations for sterile formulation facilities at a site or cluster level - Ensure reliable performance of utilities such as HVAC, cleanrooms, water systems, PW, WFI, and process equipment - Oversee preventive, predictive, and corrective maintenance programs - Ensure adherence to USFDA, EMA, MHRA, and other regulatory requirements - Maintain audit readiness and support inspections with complete documentation - Drive data integrity and compliance across engineering systems - Collaborate with global teams for standardization and best practices - Ensure energy efficiency, sustainability, and cost optimization in engineering operations Qualifications: - B.E./B.Tech in Mechanical, Electrical, Instrumentation, or Chemical Engineering - 15-20 years of experience in engineering leadership within sterile formulations manufacturing - Strong expertise in sterile utilities, cleanroom operations, and aseptic equipment - Proven track record in handling audits, regulatory inspections, and large-scale projects - Experience in multi-site cluster engineering management preferred for cluster head role In this role, you will need to demonstrate strategic leadership and decision-making skills, deep technical knowledge of sterile manufacturing engineering systems, strong compliance orientation, and documentation accuracy. Excellent stakeholder management and communication skills are essential, along with the ability to drive innovation and continuous improvement within the engineering operations. In this role at the Top 10 Pharma company in India, you will be responsible for overseeing engineering operations for sterile formulations manufacturing. Whether at a single site or across multiple sites cluster, your role will be critical in ensuring uninterrupted production, compliance with global standards, and continuous improvement of engineering systems. Key Responsibilities: - Lead engineering operations for sterile formulation facilities at a site or cluster level - Ensure reliable performance of utilities such as HVAC, cleanrooms, water systems, PW, WFI, and process equipment - Oversee preventive, predictive, and corrective maintenance programs - Ensure adherence to USFDA, EMA, MHRA, and other regulatory requirements - Maintain audit readiness and support inspections with complete documentation - Drive data integrity and compliance across engineering systems - Collaborate with global teams for standardization and best practices - Ensure energy efficiency, sustainability, and cost optimization in engineering operations Qualifications: - B.E./B.Tech in Mechanical, Electrical, Instrumentation, or Chemical Engineering - 15-20 years of experience in engineering leadership within sterile formulations manufacturing - Strong expertise in sterile utilities, cleanroom operations, and aseptic equipment - Proven track record in handling audits, regulatory inspections, and large-scale projects - Experience in multi-site cluster engineering management preferred for cluster head role In this role, you will need to demonstrate strategic leadership and decision-making skills, deep technical knowledge of sterile manufacturing engineering systems, strong compliance orientation, and documentation accuracy. Excellent stakeholder management and communication skills are essential, along with the ability to drive innovation and continuous improvement within the engineering operations.

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