Process maintenance engineer

Designation: Assistant Manager - EAM

Job Location: Bangalore

Department: Engineering and Maintenance

About Syngene

Incorporated in 1993, Syngene International has grown to become a major player in the contract research and manufacturing services domain. Syngene supports RD programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process RD, cGMP manufacturing, formulation and analytical development along with Clinical development services. Syngene specializes in research and manufacturing of small molecules and large molecules for organizations around the world. The Companys facilities are audited and certified by health authorities from India, the USA, EU, United Kingdom and Russia, amongst others, for GMP related activities.

Job Purpose: Involving in Lab Facilities, Utilities, Bio facilities, API / OSD projects with knowledge in Design and execution of Projects. He will be involved in Process understanding, design of facility , co-ordination with stake-holders , Installation and qualifications in Manufacturing and development facilities for Syngene s Bengaluru / Hyderabad operations.

Key responsibilities:

• Developing of Project proposal basis Business case requirement including Budget, Major milestones, and Basic layouts
• Design review and approval for all infrastructure projects for discovery biology, Discovery Chemistry, Development laboratories, Biologics facility
• Design and review of Safety requirements being incorporated in layouts, processes being approved for new projects.
• Develop the Project strategy w.r.t. time Schedule, cost estimates
• Establishing recording the Project s communication protocol.
• Develop a detailed Project, financial and contracting strategy, including co-ordination with various consultants, Team, vendors, and other participants in the Project
• Establishing following procedures for checking, compliance with designs and specifications.
• Project Governance - Ensuring Project updates are given to Management on Weekly / Monthly basis
• Project internal review mechanism with CFT, Consultant and contractors for design, deliverables tracking based on parameter of timeliness and CAPEX control
• Perform overall quality control of the work (budget, schedule, plans, personnel s performance)
• Compliance with SOPs, cGMP and EHSS standards
• Coordination with CFT for preparing, review and execution of utility and facility DQ, FAT, SAT, IQ,OQ and PQ.
• Design 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.
• Perform overall quality control of the work (budget, schedule, plans, personnel s performance) and report regularly on project status
• 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.
• Creation of Concept notes, URS/ drawings etc. for new projects and being approved through relevant CFT.
• 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 of Syngene Compliance.
• Collaborating with Engineering cross functional
• Ensuring Training compliance to staff as well as contractors/vendors.
• Ensuring facility and equipment commissioning and qualification of Syngene Compliance in collaboration with the Quality department.
• Adhering to the company s established processes and rules and ensuring that the team does as well.

Educational Qualification:

• BE/BTech in Mechanical Engineering.

Technical/Functional Skills.

• Good knowledge on Pharma/Biotech industry environment.
• Knowledge in GMP API 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 10-12 year of industry experience out of which 08-10 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.

Equal Opportunity Employer:

Syngene will not discriminate against any employee or job candidate based on age, color, physical ability, ethnic origin, nationality, religion, gender, family status, marital status, pre-natal status, gender reassignment, or sexual orientation, either directly or indirectly.

We shall make appropriate accommodations for eligible workers or job candidates with disabilities wherever possible.