Senior Validation Engineer - Sterile/Autoclave QE

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking an EXE / Sr. EXE – QE (Validation) to lead qualification activities for autoclaves, isolators, tanks and water systems in a sterile manufacturing environment.

IQ/OQ/PQ validation, support for Lyophilization, HVAC, and related systems, and contribution to QMS investigations are key responsibilities. The ideal candidate holds BE (Mech) or B.Pharm/M.Pharm, has hands-on validation experience, and can operate Ellab and Kaye validator systems.

Qualifications

• Bachelor level or higher in Mechanical Engineering or Pharmaceutical sciences.
• Hands-on validation experience in pharmaceutical manufacturing preferred.
• Experience with IQ/OQ/PQ protocols and sterile-process validation.

Responsibilities

• Qualify or design IQ/OQ/PQ for autoclaves, isolators, tanks and related equipment.
• Validate water systems and manufacturing skids for pharma production.
• Participate in project activities as an execution lead within pharma plants.
• Perform thermal validation including sterilization validation for autoclaves, SIP, Isolators, Lyophilization, HVAC.

Education

BE (Mech.) / B.Pharm. / M.Pharm

Tools

Ellab system

Kaye validator system

Job description

Sun Pharmaceutical Industries Ltd is seeking an EXE / Sr. EXE – QE (Validation) to lead qualification activities for autoclaves, isolators, tanks and water systems in a sterile manufacturing environment.

IQ/OQ/PQ validation, support for Lyophilization, HVAC, and related systems, and contribution to QMS investigations are key responsibilities. The ideal candidate holds BE (Mech) or B.Pharm/M.Pharm, has hands-on validation experience, and can operate Ellab and Kaye validator systems.