Process & Critical Infrastructure Maintenance Specialist II

Sun Pharmaceutical Industries Ltd; Billerica (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a Critical Infrastructure Maintenance Specialist II to support pharmaceutical facility and utilities operation, maintenance and reliability. The role emphasizes adherence to cGMPs and regulatory guidelines, with responsibilities spanning records, maintenance programs, validations, and vendor interactions.

The candidate should be capable of non-routine tasks, off-hours work, and collaborating on improvements to maintain critical systems and equipment

Qualifications

• High school diploma or equivalent required.
• Technical certification preferred.
• Knowledge of pharmaceutical plant/maintenance/manufacturing operations or related environment.

Responsibilities

• Maintain records for facility and utilities and its operation.
• Support maintenance programs aligned with cGMP engineering maintenance requirements.
• Interact with vendors for manufacturing improvements and maintain equipment.
• Support preventive, predictive, corrective, and breakdown maintenance for facilities and utilities.
• Operate facility and utility equipment and manage alarm systems.
• Follow maintenance SOPs for manufacturing and critical systems.
• Perform non-routine and off-hours tasks as needed.
• Support area validation, calibration and certification efforts.
• Assist with validation maintenance programs and equipment/process validations.

Skills

Engineering drawings

Plan and prioritize workload

Operating production equipment

Hand tools & power equipment

HAZMAT training

Aseptic techniques

Pharma Plant/maintenance knowledge

Mechanical ability

MS Office

Education

High school diploma or equivalent

Technical certification

Boiler operation license (Special License to Operate)

Electrician’s license

Tools

MS Office

Job description

Job Summary

Critical Infrastructure Maintenance Specialist II support pharmaceutical facility and utilities operation, maintenance and reliability. Maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.

Area Of Responsibility

• - Participates in maintaining records on facility and utilities, as well as its operation
• - Supports maintenance programs consistent with cGMP engineering maintenance requirements
• - Interact with and direct vendors for manufacturing improvement (i.e Clean Utilities, Boilers, Chillers, etc..)
• - Supports preventive, predictive, corrective, and breakdown maintenance to facility and utility equipment
• - Operates facility and utility equipment
• - Supports Alarm Management Program
• - Supports Alarm response Program
• - Perform non-routine and off-hours tasks as necessary
• - Support area validation, calibration, and certification efforts
• - Solve simple problems related to equipment or process
• - Support equipment, utility, and plant validation as needed
• - Follows maintenance SOPs for manufacturing and critical system equipment, and utilities
• - Follow all company policies related to job safety
• - Work under supervision using some standard procedures as well as troubleshooting and decision making
• - Participates in the troubleshooting of facilities and critical utility problems
• - Support operations improvement and maintenance projects
• - Participates in improvements and maintenance as required to support all operations
• - Support validation maintenance program
• - Supports the execution of validations for manufacturing equipment and processes as needed
• - Maintain records for manufacturing equipment, and critical systems
• - Other duties as assigned

Work Conditions:

• - Office
• - Lab
• - Shop/shipping areas
• - Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

• - Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
• - Close, distance and peripheral vision; depth perception, ability to focus
• - Ability to operate production equipment and hand tools
• - Operate hand truck
• - Operate company truck
• - Current, valid Driver's license
• - Operate computer/office machines
• - Wear Safety shoes, safety glasses, gloves
• - Lift up to 70 lbs.
• - Ability to work a flexible schedule

Travel Estimate

Up to 5%

Education and Job Qualification

• - High school diploma or equivalent required
• - Technical certification preferred
• - Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
• - Knowledge of aseptic techniques
• - Ability to read & create engineering drawings
• - State boilers “Special License to Operate” preferred
• - Electrician’s license preferred
• - Ability to plan, prioritize and organize diversified workload
• - Familiarity with use of computers and MS Office

Experience

Required:

• - Minimum 2 years related experience required, preferably in the pharmaceutical industry
• - Experience with Building Automation Systems
• - HAZMAT training
• - Proficient with use of hand tools and power equipment
• - Demonstrated mechanical ability
• - Willingness and ability to obtain Boiler Specialist License required; Current Fireman’s License preferred

Preferred:

• - Pharmaceutical industry experience
• - Formal cGMP training
• - Experience reviewing/updating Standard Operating Procedures
• - Experience maintaining operation records