Title:  Senior Executive

Job Summary:

We are seeking a knowledgeable and detail-oriented manufacturing professional to join our MES (Manufacturing Execution System) implementation core team for one of our manufacturing plant. This role is pivotal in ensuring that digital transformation aligns with GMP (Good Manufacturing Practices), regulatory compliance, and operational excellence. The ideal candidate should have a strong background in pharmaceutical production processes and a passion for leveraging technology to enhance quality, traceability, and efficiency.

Key Responsibilities:

• Act as a manufacturing SME for MES implementation in a GMP-regulated pharmaceutical environment.
• Collaborate with cross-functional teams (QA, IT, Engineering, Validation, Production) to define and document MES requirements.
• Participate in process mapping, recipe modeling, and electronic batch record (EBR) design.
• Support configuration and validation of MES modules such as:
• Electronic Batch Records (EBR)
• Weighing & Dispensing
• Equipment Management
• Material Management
• Ensure alignment with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP 5).
• Assist in data migration, system testing (IQ/OQ/PQ), and go-live readiness.
• Train end-users and provide post-implementation support and troubleshooting.
• Identify process improvement opportunities and contribute to continuous improvement initiatives.
• Coordinate with IT and automation teams to ensure seamless integration between MES, ERP, and shop floor systems.
• Participate in change control processes and ensure proper documentation of system changes.
• Monitor system performance post-implementation and support optimization efforts.
• Contribute to the development of SOPs, work instructions, and training materials related to MES usage.
• Support audit readiness and respond to internal and external audit queries related to MES.
• Facilitate workshops and feedback sessions with production teams to ensure MES usability and effectiveness.
• Track and report project milestones, risks, and issues to the MES Project Manager.

Qualifications:

• Bachelor’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.
• 7+ years of experience in pharmaceutical manufacturing operations with min 3 years on MES
• Prior involvement in MES implementation or digital manufacturing projects is highly desirable.
• Strong understanding of GMP, GDP, and regulatory compliance in pharma.
• Familiarity with batch manufacturing processes, cleanroom operations, and documentation practices.