Facility Engineer

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

The Facility Engineer is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible developing, testing, modifying, and creating solutions to technical problems.

Essential Duties & Responsibilities

• •Follow safety rules and regulations as per OSHA and other applicable agencies
• •Ensure proper maintenance of facility equipment / utilities to ensure equipment runs smoothly
• •Monitor for and ensure proper pest control activity in the facility
• •Handle validation and calibration activities for Biologics operations from writing documentation such as protocols, test scripts, deviations, draft SOPs, support calibration, alarms and risks assessment to field execution to collect samples for QC testing, cycle development studies, thermal mapping, troubleshooting, deviation resolutions, evaluating and compiling test data, preparing reports and obtaining its approval
• •Provide corporate level technical support and implement long-range reliability improve programs
• •Generate engineering documents for equipment, facility and utilities, and execute the same (project execution, vendor development)
• •Complete new equipment selection and installation as per project requirements
• •Perform Thermal Mapping on various biomedical freezers and refrigerators using Kaye Validator
• •Improve teamwork efficiency by implementing technically possible corrections
• •Maintain documentation as per company's requirement / GMP requirements
• •Maintain all HVAC systems, associated equipment, electrical equipment, plumbing systems and BMS
• •Create AutoCAD drawings, perform load calculations using Trace 700 and assist with BM Sinstallation
• •Manage and maintain Lab Gas supply demand, monitor the alarms and inventory, and change the tanks as required
• •Participate in design of architectural, electrical, plumbing, fire protection and HVAC
• •Manage the Asset ID list for equipment in use and in warehouse. Manage transportation of the equipment back and forth to warehouse and facility as required
• •Maintain and update the PM Master Schedule and Master Calibration list as required
• •Prepare the PM details and master calibration for equipment and utilities and coordinate the PM/Calibration activity
• •Prepare presentation materials, calculations, construction documents, design analysis, and completion of projects
• •Manage shipping and receiving and manage timely approval for outstanding invoices
• •Coordinate with external vendor for the PM and Master Calibration List and other maintenance tasks as
• •Maintain and coordinate the update of the floor plans and P&ID of the equipment and facility in AutoCAD or Solid works
• •Ensure proper sanitization of the facility interior and exterior
• •Daily monitoring of the BMS system and coordination with external vendor as required
• •Daily monitoring of the utilities and equipment and maintenance of the log book
• •Prepare and update the Engineering SOP as required
• •Support construction and project related activity
• •Manage all EHS programs (Environmental, Industrial Hygiene, Safety, Waste Management, and Personal Protective Equipment), regulations, processes, and initiatives
• •Manage all hazardous and biological waste. Streamline the waste management process
• •Collaborate with Manufacturing, Analytical Research and Development, Quality Assurance, Microbiology, Engineering, Supply Chain and Human Resources on a regular basis to ensure consistent application of EHS programs and positive outcomes for the organization
• •Performs other functions as required or assigned
• •Complies with all company policies and standards

Requirements

Position Requirements and Qualifications

Education:

Bachelor’s degree in Engineering, Mechanical Engineering, Electrical Engineering, or related field preferred

Experience:

• •Minimum 1-3 years engineering experience in GMP environment
• •Experience with OSHA, EPA, FDA, and local authority jurisdictions required

SPECIALIZED KNOWLEDGE AND SKILLS:

• •Excellent oral and written communication skills required
• •Ability to work independently with minimal direct supervision required
• •Computer literate and proficient in Microsoft Word, Excel, Outlook, Project, PowerPoint, etc. required
• •Adaptable, open to change and able to work in ambiguous situations and respond to new information and unexpected circumstances required
• •Demonstrated attention to detail required
• •Ability to effectively engage employees required
• •Strong interpersonal and teamwork skills including the ability to easily convey concepts and priorities to peers, customers, leadership, and cross-functional teams required

Compensation:

Facility Engineer - Base Salary Range and Yearly Bonus - $70,000 to $90,000 (dependent on years of experience and fit for the position) with up to a 10% yearly (discretionary) cash bonus

Work Environment & Physical Demands:

General Work Environment:

• •Office plus small scale manufacturing site.
• •Ability to use and wear safety protective gear/equipment (e.g. safety glasses, hard hat, lab coat, gloves, respirator, etc.) and follow safety guidelines.
• •Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
• •Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.
• •Ability to work nights and weekends as needed

Noise:

Possible moderate noise levels due to construction.

Standing/Lifting:

• •Ability to sit for an extended period.
• •Ability to stand for extended periods of time and up to 6 hours at a time.
• •Ability to climb ladders, walk on uneven surfaces, make observations and assessments from elevated heights consistent with those typically found on construction sites
• •Constant walking or motion to coordinate work and interact with co-workers.
• •Ability to lift and move up to 40 pounds on an occasional basis.

Visual:

Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Stress:

High paced demanding environment to meet ambitious project goals.

Travel:

Minimal travel to be expected, but not to exceed 25%.

Supervisory Responsibility, if any : No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.