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Lead Commissioning Engineer
3 weeks ago
Job Description:
- Responsible for leading the preparation and execution of commissioning and qualification activities for pharmaceutical facilities, including OSD, Injectable, API, Oncology, Biotechnology, and Vaccine manufacturing facilities.
- Ensures that all C&Q activities are carried out in accordance with ISPE/ASTM methodologies and GDP, GEP, C&Q Base line guides, GAMP 5 & cGMP Principles.
- Plans, develops, executes, and reports on C&Q deliverables to ensure timely and effective completion of projects.
- Coordinates with different stakeholders, including package design engineers and clients, to leverage resources and ensure Right First Time documents preparations, execution, and compliance of Commissioning & Qualification deliverables.
- Develops a deep understanding of regulatory guidelines, including USFDA, MHRA, WHO, ISO, and 21 CFR part 11, to ensure compliance and adherence to industry standards.
- Prepares and reviews commissioning and qualification protocols, standard operating procedures, and work instructions to ensure accuracy and completeness.
- Executes validation master plans, validation plans, validation documents, commissioning, and validation of Clean Room & HVAC Systems in pharmaceutical industries as per required standards.
- Prepares and reviews qualification protocols, temperature mapping protocols, layouts, and SOPs as per established procedures.
- Executes pre-commissioning and commissioning checklists for various systems, including facility and process/equipment utilities.
- Executes facility, utility, and process equipment FAT/SAT protocols/reports to ensure accurate documentation and record-keeping.
Required Skills and Qualifications:
- Degree in Mechanical or Chemical Engineering with years of experience in pharmaceutical/chemical/FMCG industries.
- Deep understanding of project commissioning and qualification activities, including facility/HVAC/clean room/black and clean utility services/process equipment within pharmaceutical OSD, Injectable, API, Oncology, Biotechnology.
- Good knowledge of project management principles, including project planning, cost management, time management, construction management, quality management, contract administration, safety management, and statutory approvals management.
Benefits:
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
- Collaborative and dynamic work environment.
Others:
- Fluent English language skills and proficiency in local language desirable.
