Manager / Senior Manager Engineering

2 weeks ago

Ghaziabad, India Unichem Laboratories Full time

RESPONSIBILITIES

  • Manage and lead the engineering department at the site, ensuring smooth operations.
  • Oversee operation and maintenance of HVAC systems and utilities.
  • Develop, implement, and monitor monthly planners and maintenance schedules.
  • Ensure readiness of the department for customer and regulatory audits; represent the department during audits.
  • Implement corrective and preventive actions (CAPA) and monitor their effectiveness.
  • Monitor and ensure compliance with process equipment and facility maintenance activities in line with cGMP requirements.
  • Maintain and control all engineering documentation required for regulatory audits.
  • Ensure compliance with all statutory and regulatory requirements related to the engineering department.
  • Manage qualification, validation, and CSV validation activities.
  • Manage change control, deviations, QRM, and all QMS-related documentation.
  • Drive implementation of cGMP, GDP, Good Engineering Practices, and Learning Management Systems.
  • Manage external vendors and contractors with proper work planning, supervision, and monitoring of activities.
  • Prepare, review, and approve SOPs and engineering drawings.
  • Prepare and monitor the engineering budget, including expenditure under various budget heads and site projects.
  • Propose and implement improvement and cost-saving plans for management approval.
  • Identify departmental training needs, ensure trainings are conducted as per schedule, and oversee allocation of roles, jobs, and responsibilities to team members and contract staff.

DESIRED SKILLS

  • Experience of handling engineering in a reputed pharmaceutical organization
  • Hands on experience in handling Utility (Chiller, air compressor, air dryers, boiler) HVAC
  • Experience in handling statutory requirements
  • Experience in facing regulatory audits, especially USFDA.
  • Good technical know-how and exposure to latest technology and process equipment
  • Ability to pivot and try new approaches when faced with challenges.
  • Very good communication (written and oral), interpersonal and conflict resolution skills.
  • Leadership, mentoring and team building skills.
  • Ability to work on multiple projects in various stages.
  • Personnel and project management skills.

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