KBI Biopharma Senior Director Facilities And Engineering in Boulder, Colorado
The Sr. Director is responsible for equipment and system performance of a cGMPbiologic drug substance manufacturing facility. The Sr. Director leads,manages, and coaches engineering and maintenance staff to ensure equipmentand systems consistently perform as intended when needed.The Sr. Director develops strategies, processes, systems, procedures,and metrics to achieve a high level of facility and equipment availability,reliability, and performance. S/He monitors equipment work orders,change controls, qualification status, and readiness. Manages facility andengineering processes associated with new product introductions. The Sr.Director is responsible for developing and implementing strategies,methods, and procedures for new and existing facilities and equipmentThe Sr. Director works to ensure alignment and coordinates with otherfunctions such as Project Engineering, Validation, Manufacturing,Process Development, Quality Assurance, and Finance. Leads efforts of theorganization across functional boundaries. Represents the functional area toclients, auditors, and inspectors.Oversees engineering and maintenance support for multiple systems,processes, or areas. Develops subject matter experts in several areas.Applies advanced approaches to develop and implement strategies,technologies, or other major improvements. Directs, reviews and approvesfacilities and engineering documents.Responsible for directing, developing and implementing the necessarycontrols and systems for the Plant Engineering, Facilities, Maintenance,and Calibration functions.You will:Manage engineering and maintenance activities for the site. Direct correctiveand preventative maintenance and repair of facilities, utilities andequipment. Direct implementation of improvements to reduce failures anderrors. Oversees multiple small projects, DEVs, CAPAs, and/or ChangeControls while ensuring their success in meeting their respective objectives.Represent the Facilities and Engineering activities during client audits andregulatory inspections.Ensure engineering, maintenance, and calibration procedures and systemsare in a state of compliance and control.Oversees training and development of the team.Establish a system of metrics and reporting to evaluate the effectiveness offacility and maintenance activities.Responsible for the employment, employee motivation, counseling,discipline and changes in status of employees supervised.Requirements:Bachelor of Science degree in Engineering (mechanical, electrical,chemical, biomechanical). In depth working knowledge of cGMP requirements.Minimum 15 years engineering experience with minimum of 10 years in biotechindustry and 5 years management experience.Demonstrated track record in:Strong orientation for quality and customer serviceHigh level of integrity and personal responsibilityStrong communication skills within all levels of an organizationAbility to align growth requirements and profit objectivesKBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or veteran status, arestrongly encouraged to apply.