Operator II – Granulation

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 45,000 - 65,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Operator II – Granulation to support setup, operation, and maintenance of granulation equipment in a cGMP environment. The role involves adhering to SOPs, batch records, and safety standards while contributing to quality pharmaceutical products.

The position requires a High School Diploma or GED and 3–5 years of regulated manufacturing experience, with flexibility for various shifts, overtime, and weekends as needed.

Qualifications

• High School Diploma or GED required.
• Three (3) to five (5) years of experience in a pharmaceutical, chemical, biochemical, food, or other regulated manufacturing environment preferred.
• Experience working in a cGMP-regulated environment required.
• Prior experience operating granulation equipment is preferred.
• Ability to read, interpret, and follow SOPs, batch records, and manufacturing documentation.
• Flexibility to work various shifts, overtime, weekends, or holidays based on business needs.

Responsibilities

• Set up, operate, monitor, disassemble, clean, and reassemble granulation equipment in accordance with approved procedures.
• Perform granulation operations while ensuring adherence to batch records, SOPs, cGMP requirements, and safety standards.
• Monitor process parameters and equipment performance to ensure product quality and process consistency.
• Conduct visual inspections to identify product defects, equipment issues, or process irregularities and elevate concerns as needed.
• Ensure equipment, tools, and manufacturing areas are thoroughly cleaned between batches to prevent cross-contamination and maintain compliance.
• Complete production documentation accurately and in a timely manner, including batch records and associated logs.
• Review, understand, and maintain training compliance on applicable SOPs and work instructions through internal learning systems.
• Support departmental production goals and performance metrics.
• Build and maintain effective working relationships with cross-functional teams.
• Work independently and collaboratively in a fast-paced manufacturing environment.
• Follow all Safety, Health, Environmental, and Quality policies and procedures.
• Provide support in other Manufacturing or Packaging operations as business needs require.
• Perform other duties as assigned.

Education

High School Diploma or GED

Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Division

Piramal Pharma Solutions

Job Title

Operator II – Granulation

Job Description

The Manufacturing Operator II – Granulation is responsible for the setup, operation, monitoring, cleaning, disassembly, and reassembly of granulation equipment in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and safety requirements. Equipment may include low-shear and high-shear mixers, mills, and fluid bed dryers.

This position plays a critical role in producing high-quality pharmaceutical products and may provide support in other Manufacturing or Packaging departments based on business needs.

Position Summary

The Manufacturing Operator II – Granulation is responsible for the setup, operation, monitoring, cleaning, disassembly, and reassembly of granulation equipment in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and safety requirements. Equipment may include low-shear and high-shear mixers, mills, and fluid bed dryers.

This position plays a critical role in producing high-quality pharmaceutical products and may provide support in other Manufacturing or Packaging departments based on business needs.

Shift Hours

Monday - Thursday, 6:00 PM - 4:00 AM

Essential Duties & Responsibilities

• Set up, operate, monitor, disassemble, clean, and reassemble granulation equipment in accordance with approved procedures.
• Perform granulation operations while ensuring adherence to batch records, SOPs, cGMP requirements, and safety standards.
• Monitor process parameters and equipment performance to ensure product quality and process consistency.
• Conduct visual inspections to identify product defects, equipment issues, or process irregularities and elevate concerns as needed.
• Ensure equipment, tools, and manufacturing areas are thoroughly cleaned between batches to prevent cross-contamination and maintain compliance.
• Complete production documentation accurately and in a timely manner, including batch records and associated logs.
• Review, understand, and maintain training compliance on applicable SOPs and work instructions through internal learning systems.
• Support departmental production goals and performance metrics.
• Build and maintain effective working relationships with cross-functional teams.
• Work independently and collaboratively in a fast-paced manufacturing environment.
• Follow all Safety, Health, Environmental, and Quality policies and procedures.
• Provide support in other Manufacturing or Packaging operations as business needs require.
• Perform other duties as assigned.

Education, Experience & Qualifications

• High School Diploma or GED required.
• Equivalent combinations of education, training, and experience may be considered.
• Three (3) to five (5) years of experience in a pharmaceutical, chemical, biochemical, food, or other regulated manufacturing environment preferred.
• Experience working in a cGMP-regulated environment required.
• Prior experience operating granulation equipment is preferred.
• Ability to read, interpret, and follow SOPs, batch records, and manufacturing documentation.
• Flexibility to work various shifts, overtime, weekends, or holidays based on business needs.

Physical Requirements

• Ability to lift up to 40 pounds regularly and assist in moving drums weighing up to 300 pounds using appropriate equipment and safe work practices.
• Ability to safely operate and work around manufacturing equipment.
• Ability to stand, walk, bend, reach, and use hands for extended periods during a scheduled shift.
• Must possess sufficient vision, hearing, and communication skills to perform essential job functions safely and effectively.
• Ability to wear required Personal Protective Equipment (PPE), including respiratory protection where applicable.
• Must be able to work in a manufacturing environment with exposure to pharmaceutical powders, chemicals, and cleaning agents.
• Must not have allergies or sensitivities that would prevent the safe performance of job duties in a production environment.

Working Conditions

• Manufacturing environment with routine exposure to pharmaceutical materials, powders, cleaning agents, machinery, and varying temperatures.
• May require the use of personal protective equipment and adherence to gowning requirements.
• Overtime and weekend work may be required based on production schedules and business needs.