Process & Critical Infrastructure Maintenance Specialist II

Sun Pharmaceutical Industries Ltd; Billerica (MA); On-site; USD 90,000 - 125,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Billerica, MA seeks a Critical Infrastructure Maintenance Specialist III to support pharmaceutical facility operations, maintenance and reliability in a cGMP environment. Focus on compliance, validation, and continuous improvement of facilities and utilities.

You will interact with vendors, execute maintenance plans, and lead troubleshooting of critical equipment to ensure uninterrupted production and safety.

Qualifications

• High school diploma or equivalent required.
• Technical certification preferred.
• Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment advantageous.
• Knowledge of aseptic techniques beneficial.
• Ability to read and interpret engineering drawings.
• License requirements (Boiler/Special License) preferred.

Responsibilities

• Maintains records on facility and utilities and its operation.
• Supports maintenance programs aligned with cGMP engineering maintenance requirements.
• Directs vendors for manufacturing improvement (e.g., Clean Utilities, Boilers, Chillers).
• Performs preventive, predictive, corrective, and breakdown maintenance on facility and utility equipment.
• Operates facility and utility equipment.
• Supports Alarm Management and Alarm response programs.
• Performs non-routine and off-hours tasks as needed.
• Supports area validation, calibration, and certification efforts.
• Assists in validation maintenance and validation of equipment/processes.
• Leads troubleshooting of facilities and critical utility problems and drives maintenance projects.

Skills

cGMP compliance

Preventive maintenance

Troubleshooting

Vendor interaction

Safety/regulatory adherence

Education

High school diploma or equivalent

Technical certification preferred

Tools

Building Automation Systems

MS Office

Hand tools & power equipment

Job description

Job Summary

Critical Infrastructure Maintenance Specialist III 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..)
• Performs 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 without supervision using some standard procedures as well as troubleshooting and decision making
• Leads troubleshooting of facilities and critical utility problems
• Lead operations improvement and maintenance projects
• Leads 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 understand engineering drawings
• State boilers "Special License to Operate 2nd fireman" preferred
• Electrician's license preferred / a plus?
• Ability to plan, prioritize and organize diversified workload
• Familiarity with use of computers and MS Office

Experience

Required:

• Minimum 4+ 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 2nd Fireman's License preferred

Preferred:

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