Assistant Manager Engineering (OSD & SVP)

Milan Laboratories

12 - 14 years

27 - 32 Lacs

dahej

Posted:6 hours ago| Platform:

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Skills Required

engineering operations qa hvac systems osd pharma plants engineering & maintenance production regulatory audits svp pharma plants

Work Mode

Work from Office

Job Type

Full Time

Job Description

Department:

Engineering & Maintenance

Location:

Dahej SEZ 2

Experience Required:

8- 12 years (Pharma Engineering OSD & SVP)

Key Responsibilities:

Lead and supervise
engineering operations and maintenance
activities for both
OSD (Oral Solid Dosage) and SVP (Small Volume Parenterals)
facilities.
Ensure
availability, reliability, and optimal performance
of all production equipment, utilities, and support systems.
Plan and execute
preventive and breakdown maintenance schedules
for critical equipment (Granulators, Compressors, FBDs, Autoclaves, Vial/Ampoule filling machines, HVAC, Water systems, etc.).
Oversee
qualification, validation, and calibration
of equipment and utilities in compliance with cGMP requirements.
Ensure uninterrupted operation of
critical utilities
(HVAC, purified water, WFI, clean steam, compressed air).
Coordinate with
Production, QA, and Projects teams
to support smooth manufacturing operations.
Implement
energy-saving initiatives, cost control, and efficiency improvement projects
.
Ensure compliance with
GMP, safety, and statutory requirements
during all engineering activities.
Manage and guide the engineering team; ensure proper training and skill development.
Prepare documentation related to
SOPs, maintenance records, change controls, deviations, and CAPAs
.
Provide support during
regulatory audits and inspections (USFDA, MHRA, WHO, etc.)
.

Desired Candidate Profile:

B.E. B.Tech (Mechanical Electrical Instrumentation) or equivalent.
8 -12 years of relevant experience in
Engineering & Maintenance
within OSD and SVP pharma plants.
Strong knowledge of
GMP requirements, cleanroom HVAC systems, sterile utilities, and pharma equipment
.
Experience in handling
regulatory audits
and compliance activities.
Strong leadership, problem-solving, and communication skills.

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