Manufacturing Engineer I
POSITION OBJECTIVE: Improve manufacturing efficiency and quality through the analysis of equipment, process and workflow. As a Manufacturing Engineer I, you will gain knowledge of our routine manufacturing processes and procedures while being a key link between the Engineering, Production and Quality departments.
Essential Job Functions/Responsibilities
· Evaluate, identify, and recommend equipment for purchase/installation; supports the installation and qualification of new equipment
· Works with Operations to understand all facets of the manufacturing process and assists in developing routine and aseptic manufacturing processes
· Supports creation of documentation for equipment evaluation and purchase (User Requirement Specifications (URS), etc.)
· Assists with routine preventative maintenance (PM) activities and general maintenance activities of equipment during downtime and shutdown
· Analyze existing processes and recommends/ designs engineering solutions to address quality, capacity, and efficiency issues; also supports introduction of new products and their processes
· Creates and maintains production batch records for existing products
· Assists Regulatory department for generation of product labeling
· Routinely observes production areas to identify process deficiencies and improvements through long term process improvements initiatives, Lean manufacturing techniques and short term Just Do Its (JDI)
· Participates in Kaizen events and support development of corrective action (CAPS’s); analyzes manufacturing deviations and escalates through root cause analysis process;
· Participates in brainstorming sessions and cross-department project teams
· Provides data for project reports, action logs, flow diagrams, and Gantt charts
· Identify potential work hazards and implement safe alternatives
· Monitors environment compliance through Facility Monitoring System (FMS)
· Achieve and maintain Aseptic Gowning Qualification
· Train Maintenance/ Operation personnel on equipment and troubleshooting techniques
· May perform other duties as assigned
Required Education & Experience
· Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Chemical, Industrial, Electrical, System, Etc.) or Applicable Sciences (Chemistry, etc.)
· 2+ years’ experience in manufacturing environment, preferably in an engineering role of a pharmaceutical/FDA regulated industry
Required Skills & Abilities:
· Understanding of cGMP requirements
· Working knowledge of aseptic manufacturing technique and ability to achieve and maintain aseptic gowning qualification
· Working knowledge of relevant manufacturing/ facility systems supporting Operations
· Strong communication and problem-solving skills
· Experience supporting root cause analysis (RCA), Lean tools, and corrective and preventative measures
· Ability to manage time and organize effectively with multiple priorities
· Strong writing skills, including technical report and equipment specifications
· Proficient with Windows operating systems and Microsoft Office programs
· Team oriented individual, as a leader or individual contributor
Preferred Skills & Abilities:
· Lean manufacturing and continuous process improvement experience
· Experience with CAD or design programs a plus
· Ability to work in an aseptic cleanroom
· Ability to work in a dynamic manufacturing environment
· Ability to lift 25 lbs.
· Travel and overtime may be necessary
· This position requires passing a pre-employment drug screen in compliance with federal drug testing rules.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.
This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.