Aseptic Manufacturing Operator (GMP)

Piramal Pharma Limited; Lexington (VA); On-site; USD 36,000 - 54,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking a Manufacturing Operator to support production activities, including preparation, filling, capping, autoclaving, sterile processes, and lyophilization. You will report to the Production Supervisor and ensure batch records and equipment function meet cGMP standards.

The role emphasizes adherence to SOPs, training of new staff, and collaboration with quality, validation, and supply chain teams.

Qualifications

• High School education or equivalent.
• 2+ years in industrial or manufacturing environment.
• Pharmaceutical/aseptic manufacturing experience preferred.
• Mechanical aptitude and ability to operate processing equipment.
• Understand and follow cGMP, OSHA and FDA requirements.
• Read, interpret and follow written instructions.
• Team player with reliability and attendance.

Responsibilities

• Comply with policies and procedures regulated by PPS and regulators.
• Perform line clearances, cleaning and sterilization of fill equipment.
• Operate and maintain production equipment.
• Weigh and check raw materials for batch accuracy.
• Execute validation protocols for processes and equipment.
• Maintain records and a clean environment per regulatory requirements.
• Read and follow GMP and SOPs.
• Review SOPs and suggest process improvements.
• Assist in troubleshooting and documentation.
• Review batch records for quality and cGMP compliance.
• Initiate action on process deviations.
• Train new operators.
• Maintain cleanliness and routine maintenance of work area and equipment.
• Collaborate with quality, validation and supply chain to meet production goals.

Skills

Mechanical aptitude

Read and follow instructions

Team player

Regulatory awareness

Process equipment operation

Education

High School education or equivalent

2+ years in manufacturing environment

Job description

Piramal Pharma Solutions in Lexington is seeking a Manufacturing Operator to support production activities, including preparation, filling, capping, autoclaving, sterile processes, and lyophilization. You will report to the Production Supervisor and ensure batch records and equipment function meet cGMP standards.

The role emphasizes adherence to SOPs, training of new staff, and collaboration with quality, validation, and supply chain teams.