Facilities Maintenance Engineer

Job Title

Facilities Maintenance Engineer

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY location

Employment Type

Full Time

Salary Range

(Base/salary)

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance a" medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) a" vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

Work Hours/ Shift/ Remote

Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

Responsibilities/ Accountabilities

• Performing daily maintenance and monitoring of manufacturing 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
• 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 cleanliness, maintenance, upkeep of the facility, premises, 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 finishing 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 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.
• Other duties assigned as required by management.

Education Qualifications

• High school diploma required with minimum of three (3) yearsa experience in mechanical maintenance and electrical work in a pharmaceutical or industrial setting.
• Bacheloras degree, advanced vocational training or education in pharmaceutical engineering, industrial engineering, or related field of study from an accredited college/university is preferred.

Experience

• Minimum of five (5) yearsa experience in a cGMP pharmaceutical manufacturing operation environment.
• Good technical knowledge of Pharma / API machinery and utility requirements.

Skills/ Competencies

• 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.
• Proficiently speak English as a first or second language.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.