Process Engineering Supervisor - Manufacturing

Department: Process Engineering

Key Responsibilities:

• Lead

  technology transfer

  from bench/pilot scale to commercial manufacturing.
• Manage

  scale-up activities

  and ensure facility/process compatibility.
• Drive

  equipment and facility fitment assessments

  during project implementation and routine manufacturing.
• Lead and coordinate

  qualification and validation activities

  (IQ, OQ, PQ) in compliance with regulatory requirements.
• Troubleshoot and resolve

  process and equipment-related deviations

  , providing robust

  engineering solutions

  .
• Manage and support

  change control

  ,

  CAPA

  , and

  investigation processes

  .
• Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Engineering) to ensure successful execution of projects.
  
• Ensure timely documentation and closure of GMP documents related to engineering and validation.
  
• Utilize

  TrackWise

  for quality and compliance documentation,

  SAP

  for inventory and equipment management, and

  MS Project

  for planning and tracking.

Required Qualifications:

• Bachelors degree in

  Chemical Engineering

  or

  Biotechnology

  .
• Minimum

  10 years

  of relevant experience in

  biotech/pharmaceutical manufacturing

  , specifically in

  process engineering

  and

  project management

  .
• Strong understanding of

  downstream & Upstream processing

  operations (Chromatography, Ultrafiltration, Nanofiltration, etc.).
• Demonstrated experience in executing

  validation lifecycle documents

  including IQ, OQ, PQ.
• Proficient in using

  TrackWise

  ,

  SAP

  , and

  MS Project

  .
• In-depth knowledge of

  GMP

  ,

  regulatory compliance

  , and

  tech transfer practices

  .

Preferred Skills:

• Strong analytical and problem-solving skills.
  
• Excellent communication and cross-functional collaboration abilities.
  
• Experience working with

  regulatory audits

  and documentation.
• Ability to work independently and manage multiple projects simultaneously.