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Head of Engineering

2 months ago

Cranbury, United States Biocon Full time

Job Purpose:

Responsible for all Engineering aspects applicable to Maintenance and Project activities, installation, maintenance and qualification of manufacturing and utility equipment. Maintain site compliance for calibration, preventative maintenance, engineering documentation, building safety etc. Maintain site safe from work and environmental perspective, as per OSHA, NFPA, DEP local regulatory authorities.


Essential Duties and Responsibilities:

  • Provide engineering guidance and support engineering team so that equipment perform at peak performance level so that product development and manufacturing can achieve their time line targets.
  • Ensure work place is safe from accident and environmental perspective following guidelines of OSHA, DEP and NFPA guidelines.
  • Ensure that the qualification of facility and equipment, as applicable.
  • Ensure and monitor calibration of new and existing specified equipment, systems and instruments is up to date.
  • Maintain Utilities like HVAC Systems, USP Water System, Boilers, Compressed Air System, Hot Water, and Electricity of the validation system s in compliance with FDA.
  • Maintain Change Control, Deviation Reports, CAPA, SOPs, and other compliance related Documentation.
  • Conduct Internal audits and Coordinate safety/compliance audits and implement post-audit Recommendations.
  • Develop safety and maintenance SOPs to train maintenance mechanics on new equipment and systems.


Supervisory Responsibilities:

To manage team of subordinates as defined by the organogram and to ensure their performance meets organizational goals and objectives.


Education and Experience:

  • Bachelor's / Master's Degree in Engineering.
  • 15 plus years of experience in managing a facility, in Oral Solid Dosage manufacturing industry.
  • Minimum 8 plus years of experience in Engineering management.
  • Must have strong verbal and written communication skills with the ability to influence opinion in matters of regulatory compliance.


Must have Valid work permit.