The role will train on 1st shift for 3+ months. Shift is 1PM - 9:30PM, M-F. Shift differential, and OT availble

Job Summary

Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.

Area Of Responsibility

• Develop and maintain records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
• Manage execution of PMP programs consistent with cGMP engineering maintenance requirements
• Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
• Perform non-routine and off-hours tasks as necessary
• Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
• Solve simple to complex problems related to equipment or process
• Perform equipment, utility, and plant validation as needed
• Review and update maintenance SOPs for plant, equipment, and utilities
• Follow all company policies related to job safety
• Work with supervision using some standard procedures as well as troubleshooting and decision making
• Troubleshoot manufacturing equipment/plant/utility problems
• Support operations improvement and maintenance projects
• Perform improvements and maintenance as required to support all operations
• Support validation maintenance program
• Execute validations for manufacturing equipment and processes as needed
• Maintain records for operations plant, equipment, and utilities
• Monitor steam utility per MA State requirements
• Manage janitorial services and plant waste stream
• 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 environmen
• Knowledge of aseptic techniques
• Ability to read & create engineering drawings
• (State boilers “Special License to Operate” or higher preferred / obtain within 6 months of employment)
• 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

Preferred:

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

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Type: Full-time

Pay: $23.00 - $26.00 per hour

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime

Ability to commute/relocate:

• Billerica, MA 01821: Reliably commute or planning to relocate before starting work (Required)

Shift availability:

• Night Shift (Required)

Work Location: One location

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