Engineering Manager/ Sr. Manager (Injectable)

Role & responsibilities

1. Responsible to lead the department.
2. Responsible to execute preventive maintenance of vial /ampoule filling m/c and washing m/c.
3. To review documents pertaining to preventive maintenance/breakdown, Calibration, Validation, qualification of machine/equipment user system/instruments as per SOP & schedule.
4. Knowledge of lyophilization. Knowledge to set Lyo cycle as per product.
5. Knowledge of Toflon, Trucking, EEMA line.
6. To monitor, maintain and review the functionality of the process and auxiliary equipment along with documentation for their intended use and life cycle management.
7. To assist in preparation of the capital budget associated with the smooth functionality of the maintenance and assigned relevant projects.
8. To update & maintain the engineering records as per SOP, cGMP, requirements.
9. To perform QMS activities as and when required, regarding CCP, CAPA, Deviation, Investigation.
10. Familiarity with GMP regulations (USFDA), EU, Enviza, ISO standards (ISO 9001), ICH guidelines (ICH Q3D), BPR review process.
11. Plant Maintenance and QMS activities of Injectables.
12. Maintaining all relevant records as per ISO, WHO & cGMP standards.
13. Checking daily routine work and Maintenance, Operation of BMS, Water System, HVAC System, Boiler and all other utilities.
14. Executing cost saving and energy saving techniques/ measures and modifications to achieve Substantial reduction and work within the budget.
15. Drive various projects for enhancing productivity, improving quality, reducing downtime, enhancing safety and energy saving as per plan.

Preferred candidate profile

Experienced candidates of Pharmaceutical Industry (Injectable's)Plant Maintenance is only required, Other industries shall not be considered.