Lead Production Operator

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 50,000 - 75,000; Full time

Job summary

Piramal Critical Care, Inc. is seeking a Lead Production Operator to support manufacturing operations and supervise shift activities.

You will ensure safe and efficient production, uphold cGMP standards, maintain accurate documentation, and help achieve production targets while assisting operators and troubleshooting issues. The role requires strong attention to detail, ability to work with the maintenance team, and effective communication within a fast-paced plant environment.

Qualifications

• High school diploma required; 3–5 years in manufacturing preferred.
• Experience in cGMP environments and batch records.
• Ability to read and interpret procedures and safety rules.
• Willingness to train and lead shifts.

Responsibilities

• Fill in for the Shift Supervisor during training or absence.
• Lead shift activities and ensure safe, compliant production.
• Enter and review SAP data for production activities.
• Maintain 5S and a clean, audit-ready manufacturing area.
• Coordinate with Maintenance to minimize production loss.

Skills

Shift leadership

cGMP literacy

SAP data entry

Troubleshooting

Safety compliance

Team collaboration

Education

High school diploma

3-5 years related experience

Tools

SAP

Job description

Mandate

Who (Must be) Mandatory: "Piramal Mandate must mandatory? All Jobs must Mandate mandatory mandatory?"

Company overview

Be the First to Apply 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.

Corporate Overview

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL's associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

Equal Employment Opportunity – Additional Statement

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law.

Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.