Description:
Company Overview
Creating a Healthier World through Accessible Biologics:
Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Position Summary
-
The Utility Operator / Mechanic is responsible for the safe, reliable, and compliant operation, monitoring, troubleshooting, and maintenance of facility utility systems and equipment supporting pharmaceutical manufacturing operations.
-
This position performs routine inspections, preventive and corrective maintenance, equipment troubleshooting, and utility system operation while maintaining a strong focus on GMP/GxP compliance, safety, equipment reliability, and accurate documentation.
-
The Utility Operator / Mechanic will work closely with Engineering, Maintenance, Manufacturing, Quality, and external service providers to ensure critical and non-critical facility systems remain operational and reliable.
Essential Duties & Responsibilities:
Utility Operations
-
Operate, monitor, and inspect facility utility systems and equipment including Water for Injection (WFI), classified Air Handling Units (AHUs), compressed air systems, and process gas.
-
Monitor Building Automation Systems (BMS and FMS) and utility performance to ensure reliable operations.
-
Perform routine rounds and document operating conditions, readings, alarms, and abnormalities.
-
Support operation and monitoring of boilers, HVAC and air-handling systems, chilled water systems, compressed air systems, process and utility water systems, pumps, motors, valves, piping systems, electrical and emergency power systems, and building support systems.
-
Respond to utility alarms, equipment failures, and abnormal operating conditions.
-
Escalate critical equipment or system issues to Engineering/Maintenance leadership.
-
Assist with startup, shutdown, isolation, and restoration of utility equipment.
-
Perform equipment checks and verify systems are operating within established parameters.
Mechanical Maintenance
-
Perform preventive, predictive, and corrective maintenance on facility and utility equipment.
-
Troubleshoot mechanical equipment and identify root causes of equipment failures.
-
Repair and replace pumps, motors, valves, belts, bearings, filters, gauges, piping components, and other mechanical equipment.
-
Perform basic plumbing and facility repairs as required.
-
Lubricate equipment and perform routine mechanical adjustments.
-
Assist qualified technicians and contractors with complex maintenance activities.
-
Maintain tools, equipment, and work areas in a clean and safe condition.
GMP / GxP Compliance
-
Perform all work in accordance with applicable GMP/GxP requirements, company procedures, safety requirements, and established maintenance practices.
-
Accurately document work performed in the computerized maintenance management system (CMMS).
-
Complete maintenance records, equipment logs, checklists, and utility operating records accurately and on time.
-
Follow approved SOPs, work instructions, Lockout/Tagout (LOTO), permit-to-work, and safety procedures.
-
Maintain appropriate documentation and records to support inspections and audits.
-
Report equipment deviations, failures, and abnormal conditions promptly.
-
Support investigations, corrective actions, and continuous improvement activities as assigned.
Safety
-
Follow all company Environmental, Health & Safety (EHS) requirements.
-
Properly use required personal protective equipment (PPE).
-
Follow Lockout/Tagout and equipment isolation procedures.
-
Safely work around electrical, mechanical, steam, hot water, pressurized systems, chemicals, and other facility hazards.
-
Report unsafe conditions, near misses, incidents, and equipment hazards immediately.
-
Participate in safety training and facility emergency response activities.
Preventive Maintenance & Reliability
-
Complete assigned preventive maintenance activities according to established schedules.
-
Identify equipment deterioration and recommend repairs before failures occur.
-
Assist Engineering with equipment reliability improvements.
-
Support installation, commissioning, and qualification activities for new or modified utility equipment.
-
Assist with contractor activities and verify work is completed according to approved requirements.
-
Maintain accurate equipment history and maintenance documentation.
Requirements:
Preferred Qualifications:
SPECIALIZED KNOWLEDGE AND SKILLS:
-
Pharmaceutical, biotechnology, medical device, or other regulated manufacturing experience.
-
Experience working in a GMP-regulated environment.
-
Valid New Jersey Boiler Operator License/Certification, where applicable to facility requirements and regulatory obligations.
-
Experience working with HVAC, refrigeration, electrical, plumbing, mechanical[CC1]
-
Experience with CMMS systems.
-
Experience with utility monitoring and building management systems.
-
Experience with steam boilers, chillers, compressors, pumps, HVAC, and water systems
Compensation:
-
Utility Operator / Mechanic – Base Salary Range and Yearly Bonus – 3 years or more of facilities, utilities, mechanical maintenance, manufacturing, pharmaceutical, biotech experience - $70,000 to $90,000 (dependent on years of experience and fit for the position) with up to a 5% yearly (discretionary) cash bonus
Hours:
-
This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST
-
The position may require day, evening, night, weekend, holiday, on-call, or rotating-shift coverage based on facility operational requirements.
-
Off-shift personnel may initially be assigned routine inspections, basic maintenance activities, housekeeping of utility areas, and simple corrective tasks with clear status reporting and escalation of issues requiring additional support
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:
-
Ability to stand and walk for extended periods.
-
Ability to climb stairs, ladders, and access utility equipment.
-
Ability to lift 50 lbs. and carry equipment and materials as required.
-
Ability to work in mechanical rooms, utility areas, manufacturing areas, rooftops, and other facility environments.
-
Ability to work in hot, cold, noisy, and potentially confined areas while following applicable safety requirements.
-
Ability to wear required PPE and respiratory protection when applicable.
Supervisory Responsibility, if any: No
This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
