Manager / Senior Manager Engineering

2 weeks ago

Ghaziabad India Unichem Laboratories Limited Full time

Job Description 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 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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