Experience - 17 – 20 Years
Qualification - B.E. / B. Tech –Electronics / Instrumentation / Mechanical
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 organizationHands on experience in handling Utility (Chiller, air compressor, air dryers, boiler) HVACExperience in handling statutory requirementsExperience in facing regulatory audits, especially USFDA.Good technical know-how and exposure to latest technology and process equipmentAbility 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.Skills Required
Cgmp, qrm, Air Compressor, deviations , Change Control, Boiler