Seeking a seasoned Engineering Manager that is looking to move into a new role as a Director. The Director of Engineering leads the team that performs the design, and development process. They will coordinate and manage the process improvement and facility expansion activities across Bachem Americas, Inc.’s (BAM) two sites.
· Bachelor’s Degree or higher in Engineering
· Minimum of 15 years of engineering and project management experience in either the Food, Medical Device, or Pharmaceutical industries
· Minimum of 5 years of experience in a managerial position in the Pharmaceutical Industry
· Experience in planning or operating Laboratory buildings, HVAC systems, clean room design, freeze drying, downstream bioprocessing, mixing, filtration, process automation and quality controls
· Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions
· Handle complete project life cycle from design, planning and implementation to validation
· Familiar with FDA requirements, cGMP guideline, 21 CFR Parts 11, 210, 211, 820
· Manage engineering team between the Torrance and Vista locations
· Excellent written and oral communication skills
· Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
· Ability to work independently and manage one’s time
· Advanced computer knowledge, including planning and design software
· Communicate effectively and ability to function well in a team environment
· Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
· Ability to improve safety through engineering design and controls
· Familiar with the operation and maintenance of Lyophilizers
PHYSICAL REQUIREMENTS
This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment. The ability to lift up to 25 lbs., push and pull 50 to 100 lbs. is required.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ENVIRONMENTAL CONDITIONS
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
· Manages the engineering team and coordinates engineering activities to design, develop, project, and improve processes materials flow
· Provides planning, direction, and coordination for all technical activities while achieving optimum use of workers, equipment, materials and facilities
· Plans and establishes engineering schedules and follows up performance against estimates
· Directs department activities to design new processes, modify existing designs, improve production techniques, and develop test procedures
· Confers with management, production, and marketing staff to determine engineering feasibilities and cost effectiveness for meeting product demand,
· Analyzes technology trends, human resource needs, and market demand to plan projects
· Drives operational efficiency in manufacturing with new technologies and process automation
· Recommends and implements new policies and procedures to improve existing processes and products
· Prepares and controls department budget, forecasts operating cost of department and prepares for budget proposals
· Ensures compliance of company policies, procedures and objectives regarding processes, initiatives, and projects
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