Production Operator

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 42,000 - 54,000; Full time

Job summary

Piramal Critical Care, Inc. in the United States is seeking a Production Operator to support manufacturing processes on the 12-hour night shift. You will operate reactors, distillation columns, and other equipment while ensuring safety and adherence to cGMP guidelines.

You will monitor instrumentation, record data, enter SAP information in real time, and coordinate with maintenance to keep production schedules. Previous manufacturing experience and the ability to read procedures are preferred.

Qualifications

• High school diploma or GED required.
• Ability to read and interpret safety rules and procedures.
• Ability to write routine reports and data entries.
• Ability to work in 12-hour night shift and maintain safety.

Responsibilities

• Operate and monitor manufacturing processes.
• Enter production data into SAP in real time.
• Assist maintenance and other departments to ensure smooth operations.
• Maintain clean and audit-ready manufacturing area.
• Follow cGMP procedures and safety rules.
• Report any injuries or near misses promptly.

Skills

cGMP knowledge

SAP data entry

Forklift operation

Problem solving

Education

High school diploma or GED

Tools

SAP

Job description

Job Title: Production Operator

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/

The role is responsible for operating and supporting manufacturing processes while ensuring safety, compliance with cGMP requirements, and achievement of production schedules. The position includes equipment operation, process monitoring, documentation, and coordination with maintenance and other departments to ensure efficient plant operations.

Night shift 12-hour 2-2-3 shift rotation schedule

Essential Duties and Responsibilities

• Follows operating procedures, rules and instructions to work in a safe fashion; is familiar with and understands all relevant procedures
• Participates in 5S and SFTI in the Manufacturing department
• Assists in troubleshooting automation and operational issues
• Enter SAP data in real time on all production processes
• Submit work orders and coordinate work with Maintenance
• Report alarms and take appropriate action
• Achieve manufacturing schedule and production goals
• Responsible for producing manufacturing batch records that are completed and accurate utilizing both electronic and manually recorded data
• Ensure manufacturing area and control systems are audit ready at all times with up-to-date documentation and a clean and organized environment
• Cooperates with management and colleagues on site to provide a safe and healthy working environment
• Reports all personal injuries, near misses, and accidents, however minor, to their supervisor and reports each in WSO
• Understand and perform work activities in accordance with Current Good Manufacturing Practices (cGMP) (21 CFR 210 & 211) in all areas of business where the cGMPs apply
• Runs reactors, distillation columns, filters, and molecular sieves
• Reads meters and gauges or automatic recording devices at specified intervals to verify operating conditions
• Operates and controls electric motors, pumps and valves to regulate flow of chemicals
• Handles highly hazardous chemicals in drums, totes, trucks, cylinders, or bulk tanks
• Adjusts manual controls or overrides automatic controls (when directed) to bring equipment into recommended or prescribed operating ranges, switch to backup equipment or systems, or to shut down equipment
• Takes samples and submits to Quality Control for analysis
• Adjusts the pH of discharged water as required
• Visually inspects equipment at periodic intervals to detect malfunctions or need for repair, adjustments or lubrication
• Records operations and maintenance actions taken on production records
• Sweeps, mops, dusts, polishes, waxes, paints, etc. as needed in accordance with the housekeeping schedule and documents all cleaning accordingly
• Operates forklift and pallet jack
• Assists other functional departments when needed including Maintenance, Packaging, Warehouse, Engineering, Quality Control, etc.

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

• Positive attitude with a strong desire for continuous learning
• Ability to plan activities for safe and reliable plant operations
• Good troubleshooting skills
• Mechanical aptitude and the demonstrated ability to perform minor repairs and maintenance

Education/Experience

• High school diploma or General Education Degree (GED) or one to two years of related experience and/or training; or equivalent combination of education and experience
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write routine reports and correspondence.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Ability to compute rate, ratio and percent; and to draw and interpret bar graphs.
• Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands

Must be able to wear face mask respirator and required personal protection equipment. Performing the duties of this job, it is regularly required to use hands to finger, handle, or feel objects, tools, or controls and talk or hear. Frequently required to reach with hands and arms and climb or balance. The employee is occasionally required to stand, walk, sit, stoop, kneel or crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job 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.

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. 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.