Job Title

DPI Facilities Engineer I

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Hauppauge, NY

Employment Type

Full Time

Salary Range

(Base/salary)

$ 65k - $75k

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 - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - 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

• Perform 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 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 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.
• Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Perform entire duties as communicated time to time by department management/designee.
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA's Safety, Health, and Environmental policies.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Other duties assigned as required by Maintenance management.

Education Qualifications

• 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.

Experience

• Three (3) years of facility maintenance experience is required.
• Pharma relevant experience is mandatory.
• Must be willing to work daily overtime to include starting work early or staying late past scheduled work hours based on business needs, if required.
• Must be willing to work some weekends based on a relevant business need, if required.
• Bi-lingual Spanish-speaking skills preferred.

Skills/ Competencies

• Must have excellent communication skills.
• Maintain a positive, professional attitude towards work and willingness to cooperate with co-workers and supervisors.

Physical Requirements

• Physical requirements: Long periods of standing up/walking during working hours; ability to ascend/decent ladders; and able to lift up to 35 pounds.
• Must communicate clearly and concisely across levels, both orally and in written.
• Strong command of written and verbal English is required.