Job Title: Mechanical Engineer
FLSA Classification: Professional, Exempt
Work Location: Fall River, MA 02720
Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)
Reports To: Facilities Engineering Supervisor

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 two to three (2-3) 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.
• Experience in Inhalation products (MDI) is a plus.

PHYSICAL REQUIREMENTS:

• This position requires the ability to do heavy lifting / bending frequently.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Ability to perform repairs to parts or equipment that may require cutting, brazing, TIG/MIG or stick welding.
• Requires the ability to work indoors and outdoors.
• Must be physically capable of climbing ladders, working with hardware, working in a lying position, working with arms extended overhead for extended periods of time.
• Ability to wear appropriate PPE is required.
• Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

The purpose of the Facilities Engineer is to assist in the mechanical/electrical maintenance, repairs, and servicing of a pharmaceutical manufacturing facility such as Utility maintenance etc.
The Facilities Engineer conducts and directs sections of manufacturing process development projects and assists in performing more complex engineering projects to evaluate, select, and adapt standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant operations.

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.