Prasad Reddy

Senior Engineering Manager with over 20 years of experience in pharmaceutical manufacturing. Expertise in engineering operations, maintenance, project management, equipment validation, and regulatory compliance (FDA, MHRA, GMP). Proven track record of leading multidisciplinary teams, delivering successful regulatory audits and driving operational Excellence across complex manufacturing environments.

Currently leading Engineering functions at a UK-Based pharmaceutical site, ensuring high equipment reliability, compliance to the audit findings within the time lines, continuous improvements and the site statutory compliance.

Senior Manager – Engineering - Bristol Laboratories UK - Bristol, UK

(2017-01)

• Lead engineering operations including maintenance, utilities management, equipment qualifications (IQ/OQ/PQ) & requalification.
• Ensure compliance with MHRA and GMP standards across site operations.
• Overall responsibility for the site projects portfolio, including preparation and implementation of CAPEX budgets.
• Ensure continuous availability and compliance of critical utilities including HVAC, purified water, steam, chilled water, compressed air, and nitrogen systems.
• Manage equipment service agreements, vendor performance, and maintenance contract negotiations and renewals.
• Drive team performance and employee development through leadership, coaching, and motivation aligned with business and departmental goals.
• Collaborate closely with HSSE and Facilities teams to ensure full compliance with statutory, environmental, health, safety, and GMP regulatory requirements
• Improving equipment uptime by 15% and reducing the maintenance cost by 10%
• Managing engineering QMS elements including deviations, CAPA, investigations, and change control.
• Lead site remediation activities, successfully closing critical audit findings within defined timelines.
• Manage the external vendors and service providers and improving service delivery.
• Over view of the calibration of the manufacturing and QC instruments.
• Member of the Quality workstream, supporting compliance activities and driving remediation actions for the closure of audit findings.
• Periodic reviews of engineering documentation, identifying gaps and ensuring full compliance with GMP and audit requirements

Manager – Engineering - Aurobindo Pharma India - India

(2005-01 - 2017-12)

• Led multiple regulatory audits (USFDA, MHRA, ANVISA, WHO).Played a key role in regulatory audits including USFDA, MHRA, ANVISA, and WHO.
• Installed and validated manufacturing and utility equipment including HVAC and water systems.
• Led engineering support for manufacturing operations and ensuring equipment availability and compliance.
• Developed SOPs for operations and preventive maintenance to ensure compliance and consistency across engineering activities.
• Managed deviations, investigations, CAPA, and continuous improvement initiatives.
• Installed and validated manufacturing and utility equipment such as HVAC systems, Purified water systems and compressed air.
• Implemented Lean, 5S, and OEE methodologies.

Executive Engineer - Neopharma UAE - UAE

(2003-01 - 2005-12)

• Managed HVAC and water systems operations.
• Supported internal audits and compliance.
• Worked with DCS, SCADA, and BMS systems.

Project Trainee - IICT India - India

(1998-01 - 2003-12)

• Contributed to hydrofluorocarbon projects.
• Developed SOPs and maintenance procedures.

Bachelor's - Chemical Engineering