Manager - Mechanical - Pharma/Bio Facilities

Job Description

Job Purpose: Involving in Lab Facilities, Utilities, Bio facilities, Mechanical, Installation and qualifications in Manufacturing and development facilities for Bengaluru / Hyderabad operations.

Key responsibilities:

- Design and execution knowledge of HVAC, Mechanical utilities and infrastructure co-ordination drawings

- Conceptualization and preparation of Layouts for biologics facility, injectable facility, laboratories design for pharmaceutical process

- Design understanding on brownfield project expansion including detailing, GAP analysis understanding and preparation of proposal including conceptual layouts, scope document, budget estimate and timeliness.

- Planning, Monitoring and controlling of Day-to- Day project activates in Projects and engg.

- Maintain a schedule & tracking of all ongoing projects. Preparing, scheduling, coordinating and monitoring the assigned engineering projects

- Perform overall quality control of the work (budget, schedule, plans, personnel's performance) and report regularly on project status

- Cooperate and communicate effectively with project manager and other project participants to provide assistance and technical support

- Collaborates with project staff to create a strategic action plan and cost estimates of materials, time, labor, and other resources required to complete the project.

- Collaborates with design group to change plans if problems arise.

- Weekly & monthly progress reports preparations & follow-ups from all project sites on daily basis.

- Support preparing project proposal which includes detailed project design, cost and timelines for all new projects.

- Follow up with field coordinators and vendors and ensure the tasks are completed as planned.

- Coordination with Consultants for GFCs.

- Identification and making standards as per current mechanical codes and standards.

- Communicate with vendors related to material dispatch and project documentation

- Creation of Concept notes, URS/ drawings etc. for new projects and being approved through relevant CFT.

- Initiation of CERs for approved project, raising PRs, follow up for POs etc

- Involving in review and execution of utility and facility DQ, FAT, SAT and IQ OQ.

- Follow up with project related vendors and monitoring work relating to Mechanical, HVAC, Clean rooms, Electrical, IT, paneling, Utilities etc.

- Understanding, reviewing changes to the drawing related to Mechanical works - HVAC, Clean utilities, Plant Utilities, Layouts etc.

- Execution of facility and equipment commissioning and qualification.

- Job analysis Preparation/Review, issuing field clearance as required.

- Ensuring Housekeeping at project site.

- Collaborating with Engineering cross functional for carry out field duties.

- Ensuring Training compliance to staff as well as contractors/vendors.

- Ensuring facility and equipment commissioning and qualification of company collaboration with the Quality department.

- Adhering to the company's established processes and rules and ensuring that the team does as well.

- Compliance with SOPs, cGMP and EHSS standards.

- Updating on day to day activates and subsequent plan with reporting manager.

Educational Qualification:

- BE/BTech in Mechanical/Electrical Engineering.

Technical/Functional Skills.

- Good knowledge on Pharma/Biotech industry environment.

- Knowledge in GMP sterile facility quality system (DI, Deviation and change management).

- Knowledge in guidelines like ASME- BPE, EU GMP, ISO 14644, ALCOA principle.

- Bioprocess/Sterile operations will be plus.

- AutoCAD and Microsoft projects Skills.

- Possess the knowledge and exposure to EHSS practices.

Experience.: Overall 13-15 year of industry experience out of which 5 years of relevant manufacturing facility construction and management experience required.

- Good knowledge in Mechanical/HVAC.

- Good knowledge in cleanroom and Biosafety levels.

- Bio process/Sterile industrial experience is preferable.

Behavioral Skills.

- Good in communication (written/oral) in English.

- Collaborative team player

- Growth mindset, positive approach.

- Quick learner.