Job Description

Client: Leading Pharmaceutical Company
Location: Multiple Sites (with 40-50% travel)
Role Overview
The Subject Matter Expert (SME) - Sterile Manufacturing is responsible for managing and supporting sterile manufacturing operations for liquid injectable products, including media, complex injectables, and suspension formulations. The role involves hands-on operation and technical oversight of manufacturing, filtration, CIP/SIP, and isolator-based equipment, along with execution of filter integrity testing including PUPSIT.The role requires extensive travel (~40-50%) to support multiple facilities, audits, and technology transfers.
Key Responsibilities
Expertise in operation of below process and equipment's:
To handle manufacturing area.
To handle process like manufacturing of liquid product including media, complex injectable and suspension manufacturing.
To handle the process equipment in manufacturing like manufacturing skid, filtration skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment's, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester etc.
Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
Handling and recording of procedure like line clearance, area cleaning and sanitization, batch manufacturing and filtration etc.
Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
To prepare of new standard operating procedure for process and equipment's.
Experience for preparation of batch manufacturing records.
To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
To handle communication with vendor and procurement team on procurement to design parts of new equipment's.
To ensure compliance to cGMP and documentation for various production activities.
Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.
Common Responsibilities
Travel (~40-50%) to our facilities for audits, training, troubleshooting, and technology transfer.
Collaborate with R&D, QA, and Engineering teams to ensure process excellence.
Author and review technical documentation, validation protocols, and reports.
Ensure compliance with global regulatory standards (FDA, EMA, WHO).
Mentor and train operators and technical staff.
Qualifications
Bachelor's/Master's in Pharmacy, Biotechnology, or related discipline.
15+ years of hands-on experience in the respective domain - sterile Manufacturing.
Proven expertise working with different makes/models of equipment or directly with OEMs.
Strong knowledge of cGMP, regulatory requirements, and validation practices.
Excellent communication, analytical, and cross-functional collaboration skills.
Willingness to travel up to 40-50% of the time.

Skills Required