SME Sterile Filling

SUN PHARMA; Panchmahal District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Sun Pharma is seeking an experienced SME Filling professional to lead aseptic filling operations at Mumbai/Vadodara. The role requires deep knowledge of filling, lyophilisation, filtration, capping, and related QA documentation.

You will train operators, perform qualification activities, and ensure cGMP compliance across the line. With 13+ years of manufacturing experience on filling lines, you will drive process improvements, review smoke studies, and coordinate with vendors and procurement to

Qualifications

• Experience in aseptic filling and lyophilisation operations.
• Knowledge of cGMP and regulatory documentation is required.
• Ability to train operators and lead qualification activities.
• Proven track record with filling lines and related equipment.

Responsibilities

• Operate and oversee aseptic filling, lyophilisation, and related processes.
• Review smoke studies and ensure corrective actions are implemented.
• Support qualification of new equipment and area cleaning procedures.
• Prepare batch manufacturing records and SOPs.
• Coordinate with vendors and procurement for parts and upgrades.
• Ensure compliance with cGMP and proper documentation.

Skills

Aseptic processing

Lyophilisation

Filtration

Process troubleshooting

Line clearance

GMP compliance

Vendor coordination

Batch records

Training operators

Equipment qualification

Education

Bachelor's degree

Tools

Filling machine

Lyophilizer

Capping machine

Filtration skid

Isolators

VHP pass box

LAF system

PUPSIT

Job description

Key Responsibilities

At Sun Pharma, we commit to helping you “

Title

SME Filling

Location

Mumbai / Vadodara

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description

• Expertise in operation of below process and equipment’s:
• To handle aseptic and lyophilisation area.
• To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process and capping.
• To handle the process equipment’s and its trouble shooting like filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP pass box, mobile LAF etc.
• Exposure to review the Smoke study of entire filling line and process like filtration, filling assembly, filling operation, aseptic intervention during filling, loading and unloading, smoke study in static and dynamic conditions. Take / suggest appropriate actions for remediation of smoke.
• Knowledge about aseptic practices, aseptic behaviours, media fill simulation, aseptic gowning and de-gowning process, aseptic area cleaning and sanitization process , personal gowning qualification.
• Good technical knowledge to train an upskill operators on filling line activities.
• Do benchmarking and propose upgradation to meet regulatory expectations.
• Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
• Handling and training of procedure like line clearance, aseptic intervention handling etc.
• Have expertise in qualification of new equipment, area cleaning and sanitization etc.
• Exposure for User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
• To prepare new standard operating procedure for process and equipment’s.
• Experience for preparation of batch manufacturing records.
• 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.

Travel Estimate

Up to 40-50%

Job Requirements

Educational Qualification

Bachelor’s degree

Experience

13+ years expertise with manufacturing filling machines and processes

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).