Engineer Level 4

JOB SUMMARY

Performs duties that require application of intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.  Develops and evaluates plans and criteria for a variety of projects and activities.  Carries out complex or novel research assignments requiring the development of new or improved techniques and procedures. 

ESSENTIAL DUTIES

• Leads and is accountable for projects and drives results.
• Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
• Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
• Develops new processes that have a significant impact on multiple disciplines. 
• Contributes to the establishment of business objectives, goals, budgets and costs as requested.
• Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.
• Mentors less experienced engineers.
• Provides broad-based direction for subordinates and colleagues within functional area and cross functionally. 
• Applies technical expertise to complex tasks with in-depth knowledge of related work areas.   
• Employs in-depth knowledge of cross functional and related technical areas, applying knowledge to other areas.
• Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.  
• Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the establishment of business objectives, goals, budgets and costs.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor’s of Science degree or Master of Science degree in Engineering preferred.
   

Experience

• Minimum 8 years experience.
• Two years of GMP manufacturing experience required.
   

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology. 
• Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
• Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
• Knowledge and ability to implement FDA or regulatory requirements as necessary. 
• Driver for acquiring resources and building consensus across products.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
• Understanding of and adherence to GMP practices and FDA regulations.
• Demonstrated ability to communicate effectively both verbally and in writing. 
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

• An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.