Director, Engineering & Facility

Kashiv BioSciences, LLC•Piscataway, NJ

23h

About The Position

Director, Engineering & Facility is a regular employee in a full-time exempt position. This employee is in charge of all engineering aspects supporting facility and manufacturing. The role involves planning, managing, and organizing engineering activities and capital investments in line with Company standards for recombinant manufacturing and sterile product filling and finishing. It also includes planning and coordinating site investments for facilities, modifications, utilities, equipment, and drug manufacturing processes in compliance with cGMP, FDA, and local regulatory expectations. The position is responsible for leading the Reliability Engineering / Maintenance Team, supervising plant-wide qualification, validation, calibration, and maintenance plans, and overseeing the design and construction of innovative devices. The Director will manage the site engineering department, establish technical standards, and participate in energy conservation initiatives. Personnel management, including training, performance management, and hiring, is also a key responsibility. The role ensures compliance with FDA regulations and contributes to a positive team climate, with accountability for delivering projects on time and within budget. The Director will lead the Engineering group to assure design and technical standards are implemented and ensure compliance and audit readiness. Coordination of resources and direct impact on project timing, budget, strategic products, sales, and standardization of delivered equipment are critical aspects. The role requires interaction with peers, subordinates, and senior personnel in a multidisciplinary and matrix environment, leading diverse professionals in a fast-paced setting, and resolving issues quickly to maintain timeliness and morale. Serving as a leadership role model and cross-functional liaison, with potential international travel for Tech transfer and facility visits, is also part of the position.

Requirements

Minimum a bachelor’s degree from a four-year university/college in Mechanical, Chemical or related Engineering field.
Post-graduate business or project management qualification preferred.
Six Sigma Black Belt or Process Improvement qualification preferred.
PE Certification (Plus)
5-7 years in pharmaceutical manufacturing
10 +years pharmaceutical and/or pharmaceutical/consumer healthcare industry experience including implementing, optimizing preventative maintenance programs
Experience with Aseptic Fill & Finish Operations, Compounding and Biotechnology drug manufacturing
Experience with vendor negotiations on price and schedule, and competitive bid practices
10 +years of previous management and leadership experience in the manufacturing engineering environment.
Prior experience in design regulations for pharmaceutical manufacturing validation to meet FDA requirements.
Background and knowledge on managing capital projects, meeting deadlines and budgets.
Knowledgeable in cGMP compliance, EHS standards, and engineering guidelines/standards.
Demonstrated successes in meeting project timelines and budgets.
Demonstrated technical understanding of the pharmaceutical industry and of best engineering practices.
Experience handling patent related activities (Plus)
Demonstrated ability to generate opinions to resolve problems, prioritize solutions, determine appropriate courses of action, gain consensus on recommendations, and implement decisions.
Ability to champion change and innovation, drive execution and results, motivate others, and foster collaboration at all levels of the organization.
Ability to delegate, train and evaluate, coach, and manage the discipline of others.
Experience in managing external contractors and service providers.
Ability to drive goals and objectives in a dynamic, and diverse work environment, drive culture, and lead initiatives.
Demonstrated organizational skills and attention to detail, ability to function in an atmosphere of constant change with attention to detail.
Demonstrated interpersonal and leadership skills; ability to function within a team-based organization.
Sense of urgency, flexibility, and accountability.
Stays current on developments in the engineering field.
Experience with BLA and FDA inspections.

Responsibilities

Plan, manage, organize, and harmonize engineering activities and capital investments in line with Company standards for recombinant manufacturing and sterile product filling and finishing.
Plan and coordinate appropriately site investment for projects encompassing facilities, facilities modifications, utilities, equipment, and drug manufacturing processes in line with cGMP, FDA, and local regulatory expectations.
Responsible for leading the Reliability Engineering / Maintenance Team’s efforts on preventive maintenance ensuring proper application of procedures for procurement of spare parts and creation of Maintenance and Calibration SOPs for all new equipment installations for a smooth transition through validation into operation.
Support as a member of the site leadership team all engineering activities and site improvement initiatives and results. Ensure objectives are aligned with site goals and objectives
Supervise plant-wide qualification, validation, calibration and maintenance plan utilizing cGMP compliant record keeping
Oversee design and construction of innovative devices including bioreactors, other upstream and downstream devices, qualification and implementation of new technology.
Direct and manage site engineering department to clearly define project objectives, map out construction and procurement strategies, identify resources necessary for project completion and develop costs and schedules to ensure flawless execution of project requirements and goals.
Establish and ensure appropriate application of technical standards and guidelines to achieve project plans and goals.
Preparation of investment, engineering and restructuring projects in collaboration with external contractors.
Ensures adequate reviews architectural, structural, mechanical, electrical, HVAC and equipment drawings for conformance to design specifications where necessary for facilities engineering efforts.
Participate in energy conservation initiative through engineering surveys, design specifications and project execution.
Direct and manage personnel activities such as training, performance management, hiring and evaluations, discipline and identification of development opportunities.
Ensure appropriate SOPs, calibration documentation, and PM checklists are developed and approved as part of project deliverables. Assure cGMP compliant Engineering drawing administration
Facility maintenance from construction, qualification and maintenance.
Support manufacturing with any equipment downtime, any facility BMS alarms and any renovation needed.
Understand FDA regulations and ensure compliance of all Engineering programs and Manufacturing operations.
Contribute fully to a climate for success in project teams: foster enthusiasm and teamwork, build relationships, reward and celebrate achievement.
This role is accountable to deliver all projects on time and within budget according to Company standards and those of the applicable regulatory authorities.
Lead Engineering group to assure design and technical standards are implemented on projects to assure quality standards.
Ensure compliance and audit readiness with Equipment, Facility and Utilities.
Coordinate resources required to complete all activities in a timely manner to meet project timelines, including projects, timelines, people and budget.
Direct impact on timing and budget for projects and consequently on future strategic products and sales.
Direct impact on standardization of delivered equipment by designing and maintaining specifications.
Influence IQ, OQ and PQ protocols and execution.
Ability to interact with peers, subordinates, and senior personnel in a multidisciplinary environment; ability to work in a matrix environment.
Must lead a diverse group of professionals and non-exempt staff in a fast-paced, dynamic environment.
Must be able to lead teams to clear hurdles or issues quickly in order to maintain timeliness, adherence to schedule, and morale. Must provide leadership to give project teams the confidence needed for success.
Serve as a role model of leadership and cross functional team liaison.
Must be able to travel internationally to assist with Tech transfer and for visits to other Kashiv facilities