Associate Director Engineering

Merck Gruppe - MSD Sharp & Dohme; Pune District; Hybrid; INR 3,000,000 - 4,200,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Merck Gruppe - MSD Sharp & Dohme seeks an experienced professional to oversee pharma process technology projects and ensure alignment with Global AH Quality strategy and regulatory requirements.

You will lead product qualifications, technology transfer, and process validation across external manufacturing sites, focusing on timely, consistent execution of global projects and continuous improvement initiatives.

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 a pharmaceutical, food manufacturing or fine chemicals environment or related academic experience.
• At least 5 years in a regulated pharmaceutical CMO environment.
• Regulatory knowledge or willingness to develop it quickly.
• GMP knowledge or willingness to acquire quickly.
• Travel up to 40% to production locations.

Responsibilities

• Provide project management and technical oversight for API-related changes, CMO transfers, and process validation.
• Lead continuous improvement initiatives to enhance process robustness and reduce cycle times.
• Support knowledge transfer involving CMOs and development of global technology platforms.
• Coordinate interfaces with QA, Regulatory Affairs, Supply Chain, and CMO teams.
• Lead or support investigations into major quality issues with AH pharma products.

Skills

Technology Transfer

Quality Systems

Process Validation

Project Management

Regulatory Knowledge

Cross-functional Leadership

Life Cycle Management

Analytical Thinking

Education

Undergraduate degree in Sciences

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:

   • i. API-related changes, including supplier and API-process changes
   • ii. CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
   • iii. Process Robustness and Product maintenance (e.g. due to regulatory changes)
   • iv. life cycle management, technical trouble shooting
   • v. Process and method validation/qualification
   • vi. 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:

   • i. Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review),
   • ii. Transfers,
   • iii. Change control for drug-products (APIs, excipients, packaging),
   • iv. Contract manufacturing site technical assessments
   • v. 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

• o Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• o 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.
• o At least 5-year Experience in a regulated environment in pharmaceutical CMO management.
• o Regulatory background requirements or motivated to acquire this quickly.
• o Strong knowledge of GMP requirements or motivated to acquire this quickly.
• o Experienced in internal business processes and organization.
• o Travel requirement: willing to travel to the different production locations (up to 40 % of the time)
• o Language requirements: English (fluent)

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

Flexible Work Arrangements: Hybrid

Job Posting End Date:09/7/2026

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