Sr Engineer Validation

SKILLS & EXPERIENCE

EXPERIENCE:  5+ years

EDUCATION:  bachelor's degree or master's degree in engineering (preferably Chemical or Mechanical)

SKILLS & ABILITIES

• Must possess strong technical skills and experience with GMP in addition to an advanced knowledge of quality audits, statistics, quality improvements, product development, chemistry, and liquid filling operations. Certification by ASQ as a CQE or CMQ/OE is preferred.
•  Excellent communication, change management and leadership skills are required in order to interface with all levels of management and to coach, train, and motivate technical staff.   
• Ability to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.
• Must possess excellent written and oral communication skills and the ability to facilitate communications between various groups to achieve quality objectives.
• Must have excellent interpersonal and leadership skills in order to effectively lead teams to meet objectives.

• Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines.

• Must be self-motivated and possess strong problem-solving and critical thinking skills.
•  Must have exceptional knowledge of FDA regulations and Good Manufacturing Practices regulations and excellent decision-making skills in order to make risk assessments and determine most efficient utilization of resources to accomplish departmental objectives.
• Domestic / International overnight travel required approximately 10% of work time.
• Must be able to stand, sit and/or walk for extended periods of time and able to lift a minimum weight of 40 lbs.
• Must possess strong technical skills. Experience with Good Manufacturing Practices is required and certification by ASQ, as a CQE, or CRE is strongly preferred. A good understanding of validation protocol, statistics, design of experiments, auditing techniques and FDA GMP regulations is necessary to make sound decisions based on available information.
• Must possess excellent written and oral communication skills and the ability to facilitate communications between various groups to achieve quality objectives.  
• Must have excellent interpersonal and leadership skills in order to effectively lead teams to meet objectives.
• Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines.
• Must have good presentation skills in order to provide training to various groups within the Company.