Droga Pharma
Engineering
Mechanical Engineering
Debre Birhan
3 years - 5 years
1 Position
2025-09-17
to
2025-09-25
mechanical engineering
Mechanical Engineering
Full Time
Share
Job Description
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).
Interested applicants can apply by our email hr@drogapharma.com
Fields Of Study
Mechanical Engineering
Skills Required
mechanical engineering
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