Equipment Specialist-2nd-Shift
PharmaBiotechQuality Assurancegmpcdminformaws
Job description
About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summar y The Equipment Specialist is responsible for maintenance and operational support of all equipment and areas needed for the manufacture of parenteral pharmaceuticals at the Baltimore fill/finish facility. Additional duties will include parts and tool management, plant equipment support, parts design, as well as management of moderately sized capital projects. This will be a 2nd-shift, on-site role. Hours-2pm-10:30pm Monday-Friday. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Comply with cGMP regulations, adhere to company policies, and adhere to SOP and Batch Record directions. Assist the Validation with the operation and execution of engineering projects. Provide technical expertise for these projects. Provide technical support during manufacturing activities. Focus on continually improving processes throughout the manufacturing and packaging areas. Coordinates and performs preventive/reactive maintenance on production and facility equipment. Maintains detailed maintenance records. Coordinates contracted maintenance activities with vendors. Assists in qualification of equipment / facilities as needed. Compiles, analyzes, draws conclusions and provides written documentation related to the maintenance and lifecycle of production systems. Administers project management controls and reports status to senior management. Involved in the oversight and coordination of activities that include design, specification creation, procurement, construction management, repair of production and facilities equipment. Researches new technologies and procedures to enhance production and performs engineering design evaluations. Applies creative and sound troubleshooting techniques to generate timely solutions to problems. Assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience and judgment to plan and accomplish goals. Assists in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems. Establish procedures with some supervision The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. Minimum Education, Experience and Skills A high school diploma or equivalent OR 2-year degree / trade school /military training OR a bachelor's degree. 3-5 years of experience in industrial/pharmaceutical engineering/maintenance setting required. Basic knowledge of electronics systems is essential. Knowledge of 2D and/or 3D electronic drafting a plus. Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully. PLC and process control troubleshooting skills preferred. Proven track record of applying broad knowledge of engineering principles, practices and procedures to the completion of moderately difficult assignments. Salary Range: 84000-126000 Compensation and Benefits We offer a comprehensive benefits package designed to support our employees’ wellbeing, including: Competitive salary and performance-based incentives Comprehensive health coverage including medical, dental, and vision insurance Retirement savings plans with employer matching contributions Paid time off Professional development opportunities Employee wellness programs and resources Employee Assistance Program and Mental Health Resources Core Values At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
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