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.

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.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Full knowledge of HVAC system with BMS controls and service to maintain them.
• DI water system maintenance and vendor coordination for the service.
• Knowledge of facility plumbing including domestic water system and sewer.
• Carpentry Skills to include Following blueprints and building plans, installing structures and fixtures, measuring, cutting, and shaping wood, plastic, and other materials, constructing building frameworks, including walls, floors, and doorframes, and repairing damaged framework or other structures/fixtures.
• Proficient understanding of HVAC systems, electrical systems and janitorial systems.
• Strong knowledge of boiler maintenance and operations.
• Strong knowledge of plumbing, building maintenance and building inspections.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.

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

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?
• Does the candidate have basic understanding of mechanical / Electrical machinery and the operating principles of control systems.?
• 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.
• Rate Your experience with SOP’s and Batch Record documentation. (1 to 5)
• Are you comfortable commuting to Fall river MA ?

Education:

• Bachelor's (Preferred)

Work Location: One location

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