Lead Production Operator

Piramal Pharma Ltd; Town of Bethlehem (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Critical Care, a Piramal Pharma unit, seeks a Lead Production Operator to support shift operations, supervise during the Shift Supervisor’s absence, and ensure safe, compliant manufacturing. The role emphasizes adherence to cGMP practices and accurate documentation.

You will collaborate with maintenance and quality teams, troubleshoot automation issues, and drive 5S/SFTI initiatives to meet production goals and quality targets.

Qualifications

• High school diploma required; 3–5 years of related experience preferred in manufacturing.
• Knowledge of cGMP (21 CFR 210 & 211) and safety procedures is advantageous.

Responsibilities

• Fill in for the Shift Supervisor during training or absence and lead the shift when the Shift Supervisor is off.
• Follow operating procedures, rules, and instructions to work safely and ensure familiarity with all relevant procedures.
• Help drive 5S and SFTI initiatives in the Manufacturing department.
• Plan, supervise, direct, and participate in daily production operations while anticipating potential production problems to minimize production loss and ensure production and quality objectives are achieved.
• Assist operators in performing their duties as necessary to meet production goals.
• Assist in troubleshooting automation and operational issues.
• Enter and review SAP data related to production activities.
• Submit work orders and coordinate work with the Maintenance team.
• Report alarms and take appropriate corrective action.
• Work with operators to verify proper operation of equipment.
• Ensure manufacturing schedules and production goals are achieved.
• Perform tasks associated with Production Operator and/or Control Room Operator duties when required, including running manual and automated process steps.
• Produce manufacturing batch records that are accurate and complete using both electronic and manual data.
• Ensure the manufacturing area and control systems remain audit-ready with up-to-date documentation and a clean, organized environment.
• Cooperate with management and colleagues to maintain a safe and healthy working environment.
• Create reports using electronic data from manufacturing systems.
• Report all personal injuries, near misses, and accidents to the supervisor and document them in WSO.
• Perform work in accordance with Current Good Manufacturing Practices (cGMP) (21 CFR 210 & 211) wherever applicable.
• Read meters, gauges, or automatic recording devices at specified intervals to verify operating conditions.
• Operate and control electric motors, pumps, and valves to regulate the flow of chemicals.
• Adjust manual controls or override automatic controls (when directed) to maintain proper operating ranges, switch to backup equipment, or shut down equipment when required.
• Perform housekeeping duties including sweeping, mopping, dusting, polishing, and waxing as needed.
• Assist other departments when required, including Maintenance, Packaging, Warehouse, Engineering, and Quality Control.
• Perform additional duties as requested by the Shift Supervisor.

Education

High school diploma

Tools

SAP

Job description

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Division

Piramal Critical Care

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Lead Production Operator

Job Description

The role supports manufacturing operations by assisting the Shift Supervisor and leading shift activities when required. The position ensures safe and efficient production operations, compliance with cGMP standards, accurate documentation, and achievement of production targets while supporting operators and troubleshooting operational issues

Essential Duties and Responsibilities

• Fill in for the Shift Supervisor during training or absence and lead the shift when the Shift Supervisor is off

• Follow operating procedures, rules, and instructions to work safely and ensure familiarity with all relevant procedures

• Help drive 5S and SFTI initiatives in the Manufacturing department

• Plan, supervise, direct, and participate in daily production operations while anticipating potential production problems to minimize production loss and ensure production and quality objectives are achieved

• Assist operators in performing their duties as necessary to meet production goals

• Assist in troubleshooting automation and operational issues

• Enter and review SAP data related to production activities

• Submit work orders and coordinate work with the Maintenance team

• Report alarms and take appropriate corrective action

• Work with operators to verify proper operation of equipment

• Ensure manufacturing schedules and production goals are achieved

• Perform tasks associated with Production Operator and/or Control Room Operator duties when required, including running manual and automated process steps

• Produce manufacturing batch records that are accurate and complete using both electronic and manual data

• Ensure the manufacturing area and control systems remain audit-ready with up-to-date documentation and a clean, organized environment

• Cooperate with management and colleagues to maintain a safe and healthy working environment

• Create reports using electronic data from manufacturing systems

• Report all personal injuries, near misses, and accidents to the supervisor and document them in WSO

• Perform work in accordance with Current Good Manufacturing Practices (cGMP) (21 CFR 210 & 211) wherever applicable

• Read meters, gauges, or automatic recording devices at specified intervals to verify operating conditions

• Operate and control electric motors, pumps, and valves to regulate the flow of chemicals

• Adjust manual controls or override automatic controls (when directed) to maintain proper operating ranges, switch to backup equipment, or shut down equipment when required

• Perform housekeeping duties including sweeping, mopping, dusting, polishing, and waxing as needed

• Assist other departments when required, including Maintenance, Packaging, Warehouse, Engineering, and Quality Control

• Perform additional duties as requested by the Shift Supervisor

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals

• Ability to write routine reports and correspondence clearly and professionally

• Mathematical ability including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals

• Ability to compute rate, ratio, percent, and interpret bar graphs and scatter plots

• Ability to apply commonsense understanding to carry out written, oral, or diagram-based instructions

• Ability to deal with problems involving multiple variables in standardized situations

• Positive attitude with a strong desire for continuous learning

• Ability to plan activities to ensure safe and reliable plant operations

• Good troubleshooting skills

• Mechanical aptitude with the ability to perform minor repairs and maintenance when needed

• Good computer and automation aptitude with the ability to operate equipment using control systems

• Ability to multitask across automated and manual systems simultaneously

• Ability to prioritize workload and delegate tasks effectively

Education/Experience

• High school diploma required

• Minimum 3–5 years of related experience and/or training, or an equivalent combination of education and experience

Physical Demands:

• Must be able to wear a face mask respirator and required personal protective equipment

• Frequently required to use hands to handle tools, equipment, and controls and communicate verbally

• May frequently be required to reach with hands and arms and climb ladders

• Occasionally required to stand, walk, sit, stoop, kneel, or crouch

• Must be able to lift and/or move up to 50 pounds

• Vision requirements include close vision, distance vision, and the ability to adjust focus

Reporting to this position:

N/A

Travel:

N/A

General Oversight and Direction:

Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions, or previous training. Employee handles some situations independently.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran, or Vietnam Era Veteran Status.

Americans with Disabilities Act

Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities

You are expected to follow all policies, procedures, and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company.

The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.