Manager / Senior Manager Engineering
2 days ago
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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