Job description

The job duties for this position include but are not limited to the following:

• Performing daily maintenance and monitoring of equipment to ensure a high level of reliability.
• Participate in designing, implementing, and monitoring, of continuous improvement in the facility.
• Assist with installation and commissioning of new equipment.
• Evaluate and repair a wide variety of machinery and equipment using acquired knowledge, skills and experience, company supplied tools, some fabrication of parts and new and/or used but serviceable repair parts.
• Raise the change controls whenever required changes are to be made in facility and equipment.
• Prepare for operation, maintenance and engineering procedures of all equipment.
• Fill the deviation report for CAPAs and change controls as per company procedures.
• Prepare & implement procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA).
• Check and monitor for cleanliness, maintenance, upkeep of the facility, premise and equipment.
• Maintain concurrent entries of all operations/activities.
• Assist with any carpentry activities to include building walls/rooms with minimal guidance, installing repairs and finish drywall to completion, priming/painting new and existing walls, ceilings, doors, etc. throughout the site internally and externally.
• Install and troubleshoot facility electrical systems.
• Coordinate in Technology Transfer / Product Transfer with other departments.
• Coordinate with other departments for compliance statutory requirements.
• Coordinate with central utility so that required quality utilities can be provided to plant.
• Raise Capital Expenditure Requisition, work orders in SAP.
• Handle and maintain the electrical distribution system and plan for energy conservation.
• Handle the preventive maintenance of production equipment and machinery.
• Breakdown and preventive maintenance of BMS equipment and instruments.
• To check daily alarms in BMS and plan their immediate, corrective and preventive maintenance.
• Operation of BMS and service floor equipment.
• Ensure the calibration activities are completed.
• Daily monitoring and maintenance of records of the purified water generation, storage, and distribution system.

Requirements:

• Engineering graduate
• 5 to 7 years of experience in manufacturing (Maintenance and Projects). At least 3 years in senior management role
• Good technical knowledge of Pharma / API machinery and utility requirements
• Good knowledge and experience in execution of green field projects
• Knowledge of GMP and various regulatory requirements
• Strong leadership skills and experience in industrial automation
• Ability and willingness to learn

Education and Experience

• High school diploma required with minimum of three (3) years’ experience in mechanical maintenance and electrical work in a pharmaceutical or industrial setting.
• Bachelor’s degree, Advanced vocational training or education in pharmaceutical engineering, industrial engineering or related field of study from an accredited college/university is preferred.
• Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Holidays
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• Are you a US citizen/ GC holder/Permanent citizen of USA (This position will not sponsor visa)
• Are you willing to do a Mandatory Drug Screening and background check, if you are selected?
• Do you have experience and knowledge of Health & Safety procedures, including OSHA?
• What is your expected annual base/fixed salary for this position?
• Do you have experience in cGMP and regulatory requirements in manufacturing environment? If Yes, Kindly mention number of years of experience.
• Are you comfortable commuting to Fall river MA ?
• How many years of experience in manufacturing (Maintenance and Projects)
• How many years of experience in a senior management role?

Education:

• Bachelor's (Preferred)

Work Location: One location

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