Mechanical Engineering for Trust Manufacturing PLC 29 views

1. During Plant Project Phase (Construction & Installation)

• Participate in design review of HVAC, water systems (PW), process piping, ETP, compressed air, and boiler systems.
• Supervise installation and commissioning of mechanical utilities, cleanroom AHUs, chillers, air compressor, boiler and process machinery and production equipment.
• Ensure compliance with WHO cGMP, ISO, and EFDA requirements during construction and installation Whichever is applicable.
• Review and approve mechanical drawings (P&ID, GA drawings, isometrics) submitted by contractors.
• Monitor contractors’ work to ensure adherence to specifications, safety standards, and project timelines.
• Conduct FAT/SAT (Factory and Site Acceptance Tests) of critical equipment.
• Support validation teams during DQ, IQ, OQ, PQ stages of qualification.
• Coordinate with civil, electrical, and automation engineers for integrated project execution.

2. During Plant Operation (Manufacturing Phase)

• Operate, maintain, and troubleshoot mechanical systems: HVAC, purified water, compressed air, steam boilers, ETP.
• Supervise preventive and corrective maintenance of production equipment (preparation vessel, filling machines and packing machinery etc.).
• Monitor energy efficiency of mechanical systems and recommend optimization measures.
• Support the engineering department in calibration and maintenance schedules.
• Prepare and maintain SOPs for mechanical equipment operation and maintenance as per cGMP requirement.
• Ensure continuous compliance with GMP, safety, and environmental standards.
• Train operators and technicians in operation and safe equipment handling.
• Support plant expansion or modification projects with technical input.

• B.Sc. in Mechanical Engineering.
• Additional certification in HVAC, utilities, or GMP compliance is an advantage.
• Experience
• Project Phase: Minimum 3–5 years in mechanical installation projects, preferably in pharmaceutical, food, or related facilities.
• Operation Phase: Experience in maintenance and operation of pharmaceutical utilities, process machinery, QC equipment’s and other mechanical related building parts (HVAC, clean utility, air compressor, steam generation and process machinery and equipment).
• Technical Skills
• Strong knowledge of HVAC cleanroom design (ISO classifications, Grade A–D, HEPA/ISO 16890 standards).
• Familiar with utility systems (chillers, boilers, purified water, compressed air, vacuum for product transfer system, ETP).
• Ability to read and interpret mechanical drawings, P&ID, and equipment manuals.
• Familiarity with cGMP, WHO TRS guidelines, ISO standards, and EFDA regulatory requirements.
• Proficiency in AutoCAD or similar design software.
• Soft Skills
• Strong problem-solving and analytical skills.
• Good communication skills to coordinate with cross-functional teams.
• Leadership to supervise contractors and technical staff.
• Strong documentation and reporting discipline (essential for cGMP audits).