Associate Director Engineering

MSD Malaysia; Pune District; Hybrid; INR 1,500,000 - 2,500,000; Full time

Job summary

MSD Malaysia is seeking a senior professional to manage pharma process technology projects, ensuring consistent execution across external manufacturing sites. You will lead CMO transfers, API changes, and lifecycle improvements while coordinating with Quality, Regulatory Affairs, and Supply Chain teams.

The role requires extensive experience in regulated pharma environments, strong GMP knowledge, and ability to lead cross-functional teams across global projects.

Qualifications

• Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• At least 10 years of experience in technology or manufacturing in pharma, food, or fine chemicals sectors or equivalent academic experience.
• At least 5 years of experience in a regulated pharmaceutical environment with CMO management and regulatory familiarity.

Responsibilities

• Provide project management and technical oversight for drug-product manufacturing sites for API-related changes, CMO transfers, and validation activities.
• Drive continuous process improvement to reduce cycle times, improve Right First Time outcomes, and support life cycle management.
• Lead knowledge transfer with CMOs and support development of global technology platforms and tech networks.
• Facilitate coordination between manufacturing sites and Quality, Regulatory Affairs, and Supply Chain Management to ensure alignment and timely execution.

Skills

Adaptability

Cross-functional leadership

Project management

Communication

Travel coordination

Education

Undergraduate degree in Sciences

Job description

Job Description Summary of Position: This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements. The position holder is responsible for and should have experience in product qualifications and technology transfer, process improvement, and process validation. The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment. The manufacturing sites that are supported by the person in this position will include third parties producing AH Pharma products. The position holder will concentrate his/her activities primarily on the support of Global projects at external manufacturing sites.

Major Assignments

1. Provide project management and/or technical oversight, planning, coordination and support to drug-product manufacturing sites for projects related to:
   • API-related changes, including supplier and API-process changes
   • CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
   • Process Robustness and Product maintenance (e.g. due to regulatory changes)
   • life cycle management, technical trouble shooting
   • Process and method validation/qualification
   • Overarching changes to products or materials.
2. Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites. Projects include:
   • Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review)
   • Transfers
   • Change control for drug-products (APIs, excipients, packaging)
   • Contract manufacturing site technical assessments
   • Qualification/validation approaches.
3. Support of direct knowledge transfers involving CMOs, support of development of global key technology platforms, technical expertise and its technology network.
4. Facilitation of communication and interface for manufacturing sites to other global/local departments such as Quality, Supply Chain Management, Regulatory Affairs, Pharma R&D, Global Supplier Management, and CMO Organization.
5. Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products.

Skills

• Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• At least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
• At least 5-year Experience in a regulated environment in pharmaceutical CMO management.
• Regulatory background requirements or motivated to acquire this quickly.
• Strong knowledge of GMP requirements or motivated to acquire this quickly.
• Experienced in internal business processes and organization.
• Travel requirement: willing to travel to the different production locations (up to 40 % of the time)
• Language requirements: English (fluent) Understanding Others - Core Cross-Functional technical expertise, credibility, innovative- Core Hiring and Staffing - NA Team Leadership and Integration - Core Innovation Management - Advanced Consulting and Process Re-engineering - Advanced Managing Diversity - Core Technical Risk Analysis - Advanced Directing Others - Core Supply Chain Knowledge - Awareness Conflict Management - Advanced Quality Knowledge - Advanced Intercultural Management (US, Europe, ROW) - Advanced Pharmaceutical Technology - Advanced Regulatory Affairs - Awareness

Required Skills

• Adaptability
• Adaptability
• API Manufacturing
• Business Process Creation
• Change Controls
• Chemical Engineering
• CMO Management
• Customer-Focused
• Data-Driven Decision Making
• Drug Product Development
• Equipment Qualification
• Estimation and Planning
• External Manufacturing
• Life Cycle Planning
• Manufacturing Quality Control
• Manufacturing Technologies
• Operations Management
• Pharmaceutical Manufacturing
• Pharmaceutical Process Development
• Process Capability Analysis
• Process Control Automation
• Process Design
• Process Implementations
• Process Improvements
• Process Maturity
• + 10 more

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 09/7/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.