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Maintenance Manager

Company: ImprimisRx
Location: Ledgewood
Posted on: February 25, 2021

Job Description:

ImprimisRx is one of the nation's leading ophthalmology compounding businesses. We are headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRx's 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities.We are searching for a dynamic, organized self-starter to lead our Maintenance and Facilities initiatives based out of our Ledgewood, New Jersey facility. The ideal candidate will be a team player who will lead and motivate our Maintenance Mechanic team. In addition, he/she will possesses the skill and vision necessary to ensure facility, manufacturing, filling, packaging support equipment and utilities are all operating at peak performance and maintained at the highest cGMP and EHS standards for the company. This position will report to the VP of Manufacturing and Technical Services and lead the teams who support the aseptic manufacturing in both our 503A and 503B facilities. ImprimisRx is a fast-paced and dynamic environment and the candidate must demonstrate the ability to transition between hands-on and management delegation with a strong sense of urgency.Position Responsibilities* Dedicated to supporting multi-suite sterile drug manufacturing facility by working in a safe and productive manner; and must be self-motivated and team centric.* Develop and implement solutions to difficult problems, manage outside contractors and be on call for emergencies.* Handle multiple projects and daily activities, meet deadlines and execute plans that accomplish departmental objectives.* Ensure that all safety programs and procedures are followed, develop and maintain preventative maintenance programs and good working relationships with operations.* Provide leadership and direction to the Maintenance Mechanic Personnel by motivating and providing direction to help them achieve their goals and make a consistent effort to go above and beyond* Ensuring compliance to OSHA and cGMP regulations and working in collaboration with a cross functional team to ensure that Engineering, Maintenance and Facilities projects and programs meet the required standards of the internal and external customers.* Planning, Organizing, directing and implementing engineering and maintenance services for capital projects, continuous improvement projects and overall facility maintenance activities.* Develop/implement preventive maintenance program in conjunction with operations, maintenance staff, and quality to comply with regulatory guidelines.* Conducts investigations, root cause analysis with implementation of effective CAPA's for non-conformances related to facilities, equipment and utilities.* Coordinate with third party contractors to lead and schedule site calibration activities across two facilities.* Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and team can excel and continuously improve around culture and processes.* Maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance.* Direct responsibility for capital projects, as well as the site's capital and expense budgets, cost control, project schedules, and direct/indirect expenses.* Support procurement strategy, equipment expediting/projects and URS/FAT/SAT/IOQ/PQ.* Construction management in compliance with all applicable safety, regulatory and legal requirements.* Ensure that appropriate training of all personnel for equipment, process and facility safety and operations is maintained and up to date.* Maintain regulatory compliance through audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support.* Provide oversight and technical expertise during the development of new strategic manufacturing platforms and products and implementation of new technology.* Develop budget proposals and control charges against approved budget and monitor/report expenditures.* Has operational responsibility/accountability for site maintenance activities including the repair, maintenance and installation of equipment and the maintenance of buildings, grounds, utility systems with associated infrastructure.* Recommend measures to improve production methods, equipment performance, and quality of work product.* Review new product plans, and discusses equipment needs, and modifications with maintenance staff.* Manage spare parts inventory to balance cost control with operational reliability.Requirements and Qualifications* Bachelor of Science in Mechanical Engineering or Electrical Engineering with a minimum of five years' professional experience in GMP manufacturing engineering.* Minimum 3 years' experience in direct management and supervision of small teams in a GMP manufacturing environment.* Must have experience in cost control, safety, and GMP quality systems.* Hands on experience working on equipment and utilities.* Ability to plan for short, mid and long-range goals.* Experience in implementation and use of Kaizen, Lean Manufacturing, a plus.* Experience in all aspects of engineering project management and Strong knowledge of GMP manufacturing processes.* Strong interpersonal skills, including the ability to effectively and efficiently communicate in oral and written forms at any level within the organization and interact effectively with customers and external business professionals.* Strong program/project management, leadership, team building and mentoring skills. Must be able to drive business relevant projects and ensure a positive impact for both internal and external customers.* Ability to identify and implement process improvements, implement creative or novel solutions under minimal supervision.* Commitment and drive to improve manufacturing operations.* Ability to travel as required up to 10%.* Perform other duties, as assigned.Position Type and Expected Hours of WorkThis is a fulltime exempt position based in Ledgewood, NJ.Work Environment & Physical DemandsWhile performing the responsibilities of the job, the work environment characteristics are representative of the environment the job holder will encounter, and the physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions.* The employee may frequently be required to sit and talk or hear.* The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch.* The employee must occasionally lift and/or move up to 50 pounds.* May work with hazardous materials and chemicals.* Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.We offer excellent benefits and competitive salary. AAP/EEO StatementImprimis believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a "can-do" attitude and fostering a collaborative and mutually supportive environment.Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation. Imprimis Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.

Keywords: ImprimisRx, Newark , Maintenance Manager, Professions , Ledgewood, New Jersey

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