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 required by OSHA and other applicable agencies.
- Ensure proper maintenance of facility equipment and utilities to support smooth operation.
- Monitor and ensure proper pest control activity throughout the facility.
- Handle validation and calibration activities for Biologics operations, including writing documentation such as protocols, test scripts, deviations, draft SOPs, calibration support, alarms, and risk assessments; performing field execution; collecting samples for QC testing; conducting cycle development studies and thermal mapping; troubleshooting; resolving deviations; evaluating and compiling test data; preparing reports; and obtaining approvals.
- Provide corporate-level technical support and implement long-range reliability improvement programs.
- Generate engineering documents for equipment, facilities, and utilities, and execute related activities, including project execution and vendor development.
- Complete new equipment selection and installation in accordance with project requirements.
- Perform thermal mapping on various biomedical freezers and refrigerators using the Kaye Validator.
- Maintain documentation in accordance with company and 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 BMS installation.
- Manage and maintain laboratory gas supply and demand, monitor alarms and inventory, and change tanks as required.
- Participate in the design of architectural, electrical, plumbing, fire protection, and HVAC systems.
- Manage the Asset ID list for equipment in use and in the warehouse, and coordinate transportation of equipment between the warehouse and facility as required.
- Maintain and update the PM Master Schedule and Master Calibration List as required.
- Prepare PM details and master calibration documentation for equipment and utilities and coordinate PM and calibration activities.
- Prepare presentation materials, calculations, construction documents, design analyses, and support project completion.
- Manage shipping and receiving activities and ensure timely approval of outstanding invoices.
- Maintain and coordinate updates to facility and equipment floor plans and P&IDs using AutoCAD or SolidWorks.
- Ensure proper sanitization of the facility interior and exterior.
- Perform daily monitoring of the BMS system and coordinate with external vendors as required. Monitor utilities and equipment daily and maintain associated logbooks.
- Prepare and update Engineering SOPs as required.
- Support construction and project-related activities.
- Manage all EHS programs, including Environmental, Industrial Hygiene, Safety, Waste Management, and Personal Protective Equipment programs, as well as related regulations, processes, and initiatives. Manage all hazardous and biological waste and streamline the waste management process.
- Collaborate regularly with Manufacturing, Analytical Research and Development, Quality Assurance, Microbiology, Engineering, Supply Chain, and Human Resources to ensure consistent application of EHS programs and positive organizational outcomes.
- Perform other functions as required or assigned.
- Comply with all company policies and standards.
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
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
The salary range for this position ranges from $95,000 - $110,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.
