Manager Process Engineer and Projects Engineering - API

Role

To lead process engineering activities for API manufacturing facilities, including design, optimization, and implementation of advanced technologies, while supporting capital projects and ensuring compliance with cGMP and regulatory standards.

Key Responsibilities:

Process Design & Engineering:

• Develop

  Process Flow Diagrams (PFD)

  and

  Piping & Instrumentation Diagrams (P&ID)

  for API processes.
• Prepare

  Process & Utility Equipment Data Sheets

  and ensure

  standardization

  across all API facilities.
• Create

  General Arrangement Drawings (GADs)

  and detailed engineering documentation.
• Conduct

  debottlenecking studies

  to improve capacity and efficiency.
• Implement

  advanced technologies

  for process improvement and automation.
• Product mapping, capacity calculation.

Project Execution & Capex Management:

• Prepare

  Capex proposals

  , technical specifications, and procurement documents.
• Monitor

  Capex utilization

  , procurement progress, and ensure timely delivery of equipment.
• Track

  project budgets

  and report variances proactively.

Utilities & Compliance:

• Integrate

  HVAC systems

  ,

  Water Systems (Purified Water, WFI)

  , and clean utilities into process design.
• Support

  commissioning, qualification (IQ/OQ/PQ)

  , and validation activities for process equipment and utilities.
• Ensure compliance with

  cGMP

  ,

  FDA

  , and other regulatory guidelines.

Continuous Improvement:

• Drive

  energy efficiency

  ,

  cost optimization

  , and

  process reliability

  initiatives.
• Collaborate with cross-functional teams for troubleshooting and process optimization.

Key Skills & Competencies:

• Expertise in

  API process engineering

  ,

  HVAC

  ,

  Water Systems

  , and clean utilities.
• Strong knowledge of

  cGMP

  ,

  regulatory guidelines

  , and

  safety standards

  .
• Proficiency in

  engineering documentation

  (PFD, P&ID, GADs, Data Sheets).
• Analytical and problem-solving skills with ability to manage multiple projects.

Preferred candidate profile

Qualifications & Experience:

• Education:

  B.E./B.Tech in Chemical Engineering / Pharmaceutical Engineering.

• Experience:

  10 to 12 years in API process engineering and project execution.
• Exposure to

  Capex planning

  ,

  procurement

  , and

  advanced technology implementation

  preferred.