Lead Technician, Operations
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Job Description Job Description - Lead Technician, Drug Product Operations: Responsibilities may include but are not limited to; Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and SMEs. Support production activities for the commercial manufacture/fill/inspection of material Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for the production. Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product. Maintains, inventories, and transports all required equipment, materials, supplies and products. Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job-aides, and learning documents. Performs general maintenance and assists or ability in troubleshooting of equipment independently. Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel. Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required independently. Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones. Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process. Analyzing and implementing initiatives, training programs, and systems that will help to increase overall success within the department. Participate in training for new hire training programs. Participates in product/material inspection efforts Work flexible hours to support 1st/2nd DP shifts, as well as the overall process. Position will primarily support 1st shift Drug Product Operations, M-F, 6:00 AM-2:30 PM. Education Minimum Requirement: High School Diploma/GED or higher Required Experience and Skills: Minimum three-year relevant work experience in GMP environment Demonstrated written and verbal communications skills Must be willing and able to lift 50 lbs and work on elevated platforms Preferred Experience and Skills (General): Demonstrated 2-4 years of leadership experience Applicable mechanical and project management experience Proficiency with automated systems (MES, SAP, DeltaV) Experience training others and/or leading hands-on or instructor-led training Demonstrated knowledge of Lean Six Sigma/MPS principles Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability to work both independently and as a part of a team Strong collaboration, communication, and leadership skills #MSJR The salary range for this role is: $77,700 - 122,300 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. #MSJR VetJobs #EBRG's Required Skills: Adaptability, Analytical Problem Solving, Cleanroom Gowning, Cleanroom Operations, Computer Literacy, Data Analysis, Equipment Maintenance, Good Manufacturing Practices (GMP), Inventory Management, Master Batch Records, Process Optimization, Production Scheduling, Shift Work, Sterile Filling, Teamwork Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, natio
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