The Facility Engineer participates, coordinates and executes technical optimization projects and oversees ongoing maintenance and operation of the facility, and equipment, and utilities including purified water systems, compressed air systems, boilers, HVAC systems, and packaging and manufacturing equipment. He/she shall fully comply with all regulatory / cGMP guidelines, standards, and policies. This position reports to the Manager, Engineering.

Major Tasks, Key Responsibilities and Key Accountabilities:

• Personnel in this position will adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Develop equipment Specifications (User Requirements and Functional Specifications).
• Develop and review specifications and submittals.
• Participate, coordinate and execute Factory Acceptance Testing (FAT’s)
• Develop and execute Design of Experiments (Engineering Studies) for process/packaging process
• Assist in development and review of Installation, Operation, and Performance Qualification.
• Participate and/or execute Packaging Line/Process/Facility Qualification and Validation activities.
• Assist in troubleshooting equipment and utility malfunctions and breakdowns.
• Champion Operational Improvement initiatives
• Provide technical or consulting inputs on process or equipment modification.
• Establish/maintain key performance indicators.
• Support maintenance and/or facilities management activities as needed.
• Support technical & process disciplines in internal and external project efforts.
• Support and maintain cGMP critical instrument PM’s, calibrations, repairs.
• Supports investigations and assist in development and implementation of CAPAs.
• Other related duties as assigned to meet departmental and Company objectives.
• Responsible for establishing and maintaining inventory of spare parts.
• Responsible for measuring and recording measurements (voltage, amperage, RPM, etc.) and maintaining proper documentation regarding equipment/system performance and maintenance.
• Responsible for notifying supervisor or manager regarding equipment performance and maintenance.
• Must participate and successfully complete all training as required by the company.
• Responsible for overseeing the activities of contractors working on-site and ensuring they are trained on the appropriate procedures and systems, prior to performing work.
• Commitment to high level of ownership of safety, hygiene, quality and cGMP practices.
• Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, calibration, and operation of equipment, facility, and utilities.
• Follows all department SOPs and all applicable company SOPs.
• Prepare for and participate in both internal and external safety and cGMP audits
• Assist in developing and revising standard operating procedures.
• Responsible to prepare and update drawings and layouts using AutoCad.
• Responsible for training and development of new and current employee on manufacturing responsibilities including cross-training to maximize departmental knowledge
• Participate in department or company projects/initiatives as requested.
• Interact with Operations/Manufacturing, Quality, R&D, Supply Chain, etc. to resolve any issues regarding manufacturing and production related processes.
• Responsible for all documentation for water system, work orders, Rees, Optel, schedules PMs, Calibrations
• Responsible for contacts outside vendors for scheduling
• Oversees all work performed
• Oversees safety

Qualifications/Competencies/Skills:

• Good interpersonal and communication skills to deal with an array of different departments and outside vendors.
• Demonstrated oral and written communication skills.
• Strong Technical Writing skills.
• Ability to establish detailed project timelines, execute tactical plans and maintain established deliverables.
• Demonstrated problem solving skills in identifying and resolving issues.
• Ability to develop and maintain strong working relationships with primary support functions; Operations, Quality, and Safety.
• Experience with Computerized Systems including Quality Managements Systems and ERP systems.
• Proficient with Microsoft office with working knowledge of Microsoft Project.
• Proficient with AutoCad or AutoCad LT.
• Demonstrated ability to follow simple and complex procedures.
• Ability to quickly adapt and contribute.
• Strong analytical thinking and the ability to articulate rationale in a clear and concise manner.
• Ability to develop and manage aggressive timelines.
• Great attention to detail, quality and a desire for success.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Self-motivated individual with the ability to lead/drive through the change management cycle.
• Ability to write routine reports and correspondence.
• Ability to work autonomously, producing necessary results with minimal supervision/oversight
• Ability work in a controlled and regulated environment.
• Excellent verbal and written communication skills and ability to work collaboratively in a cross functional team environment.
• Knowledge of Food and Drug Administration (FDA) guidelines and cGMPs.

Education and/or Experience:

• Bachelor of Science in an Engineering related field (Mechanical, Chemical, Electrical, Manufacturing) and minimum of 2-5 years relevant pharmaceutical manufacturing experience.
• Lean Manufacturing Experience a plus.

Work Environment:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Frequently exposed to moving mechanical parts; high, precarious places and risk of electrical shock. The employee is occasionally exposed to wet and/or humid conditions; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme cold and extreme heat.
• Noise levels in the work environment is usually moderate to loud.