Responsible for the staffing, training, and leadership of the operations group supporting asset delivery, process development, operational readiness, start up, and validation of the Kenosha parenteral expansion
Lead all aspects of the day-to-day activities of their operational area as well as planning for the 3 - 6-month horizon
Provide coaching to others in the areas of safety, quality, operational execution, sterility assurance, and continuous improvement
Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area
Responsible for a work force of approximately 25 - 50 individuals on various shifts, with multiple shift supervisors reporting directly to them
Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations
Provide leadership and develop objectives to deliver Business Plan Goals as it relates to production volumes, financial, safety, quality, stewardship, and people
Maintain metrics to measure performance against business objectives and make needed changes to improve performance
Participate in the development and implementation of strategies associated with the area sponsoring or supporting initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE)
Requirements
Bachelor's degree in a science, engineering, or pharmaceutical related field of study
5+ years experience working in the pharmaceutical manufacturing industry
2+ years management or leadership experience including leading or working effectively with a cross functional group
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA
Excellent interpersonal, written, and oral communication skills (preferred)
Strong technical aptitude and ability to train and mentor others (preferred)
Previous experience in operations (preferred)
Previous experience in automated, semi-automated inspection, and manual inspection (preferred)
Previous experience with highly automated equipment (preferred)
Previous experience with creation of Standard Operating Procedures, Work Instructions etc. (preferred)
Previous experience with equipment design documentation reviews (preferred)
Previous facility or area start up experience (preferred)
Previous equipment qualification and process validation experience (preferred)
Previous experience with Manufacturing Execution Systems and electronic batch release (preferred)
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs (preferred)
Previous experience in statistical process control and Six Sigma concepts (preferred)
Previous experience with documentation, deviation and change management systems (e.g., Trackwise, Veeva QualityDocs) (preferred)
Benefits
eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug benefits
flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
life insurance and death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
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