Manager / Sr. Manager - Operations ( PFS)

We are hiring for Manager / Sr. Manager for Operations (expereince into PFS)

Department:

Reports To:

Location:

Role Summary:

Lead for the PFS line in a greenfield injectable manufacturing facility, you will be responsible for overseeing the installation, qualification, and operation of a state-of-the-art aseptic filling line for pre-filled syringes. This role is critical in ensuring compliance with USFDA regulations, achieving production targets, and maintaining the highest standards of sterility and quality.

Qualification and media fills to make the line ready for EBs/commercial batches.

Key Responsibilities:

• Project Phase (Greenfield Setup):

1. Collaborate with project teams, and validation teams during equipment installation, commissioning, and qualification (IQ/OQ/PQ).
2. Participate in FAT/SAT and CSPE (Comprehensive Scientific Process Engineering) activities to ensure seamless integration of filling line, isolator, and freeze dryer
3. Support cleanroom readiness, layout finalization, and utility mapping for the PFS line.

• Operational Phase:

1. Lead day-to-day operations of the PFS Line 3, ensuring adherence to cGMP, aseptic practices, and batch production schedules.
2. Supervise a team of operators and technicians, ensuring proper training and compliance with SOPs.
3. Monitor line performance, troubleshoot issues, and drive continuous improvement using IPAS (Intelligent Production Assistance Services)
4. Ensure zero-touch transfer and contamination control through isolator-based operations

• Compliance & Documentation:

1. Maintain all documentation related to batch records, deviations, CAPAs, and change controls.
2. Ensure readiness for regulatory inspections (USFDA, EU-GMP, etc.).
3. Coordinate with QA, Engineering, and Validation teams for audit preparedness.

Qualifications:

• B.Pharm / M.Pharm / B.E. (Mechanical, Chemical, or related field).
• 812 years of experience in sterile injectable manufacturing, with at least 3 years in a supervisory role on PFS lines.
• Hands-on experience with aseptic filling lines, isolators, and lyophilizers.
• Strong understanding of USFDA, EU-GMP, and data integrity requirements.

Preferred Skills:

• Experience in greenfield project execution.
• Familiarity with digital tools like IPAS, SCADA, and MES.
• Strong leadership, communication, and cross-functional collaboration skills.