Job Description
Purpose
Engineering Project Manager will be required for Handling Project Engineering Activities of Satara Site Facility Installation & commissioning for Pharmaceutical facilities, systems in new site as per Rubicon systems. He should handle Civil, Mechanical, Electrical, HVAC execution with planning, Coordination with consultants, vendors, Bill certification area & equipment qualification/validation, Material estimation as per design and coordination with procurement team.
Position/Job Title
Senior Manager
Department
Engineering department
Reporting To
Project head
Location
Satara
Years Of Experience
10 to 15 years experience in Regulated Pharma Engineering projects execution and qualification of utilities, pharmaceutical manufacturing and packing equipment, quality control laboratories, ETP with engineering team, vendors, plant engineering , safety Compliance to statutory guidlines.
Dosage Form
Formulation solid, liquid , injectable, Nasal
Job Responsibilities/Deliverables
Coordination with the site project team and other functions such as quality, operations for design & execution of facilities and equipment
Coordination with external vendors for civil, mechanical, electrical, instrumentation for execution activities as per design with safety, quality, statutory compliance and timelines
QMS handling which includes SOP, schedules, calibrations and IQ, OQ, PQ validations, Change control & deviation handling.
Coordination with vendor, Preparation of BOQ / techno commercial comparison chart, Raising Purchase request. Coordination with the Purchase department for releasing purchase orders. Follow up with vendors for material. Bill certification
Coordination for statutory layouts and permissions such as Boiler, factory Inspector, Electrical Inspector , MPCB etc
Project management includes preparation of Gantt Charts, monitoring the project as per Gantt chart, coordination with vendor and actual site work monitoring.
Qualifications & Pre-Requisites
BE Mechanical or Electrical (10 to 15 years experience)
Experience in handling USFDA/ EMEA approved facility project engineering for Pharmaceutical Formulations
