Process Engineer, III/Senior

The Process Engineer plays a key role supporting operations at Genezen’s gene therapy clinical/commercial manufacturing facility and will provide operational support to all development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, and leadership of medium to large projects. 

This position will be filled at the Engineer III or Sr. Engineer level, dependent upon the qualifications and experience of the successful candidate.

• Provides technical support to development and manufacturing groups, utilizing data analysis and evaluation of multiple variables. Develops solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives.
• Drives key equipment, control system, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule, budget, and overall project performance.
• Provides technical input for product tech transfers, evaluation of process requirements versus facility capabilities.
• Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
• Works independently to develop department procedures, standards, and specifications
• Other duties as assigned.

KNOWLEDGE, SKILLS & EXPERIENCE

B.S. in Chemical or Mechanical Engineering

5+ Years of relevant working experience in comparable position (similar type of work, similar group dynamics)

Excellent interpersonal, teamwork, and leadership skills

Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.

Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues.

Must be able to plan, coordinate, perform, and document work with minimal supervision.

Proficiency with Microsoft products and ability to learn additional applications as needed.

Must be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring

Proven experience and proficiency troubleshooting process and process support system issues.

Must be familiar with process control system programming and operation.

Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations.

A valid driver’s license is required for travel to vendor and / or consultant offices.

Travel to accommodate vendor visits, domestic and international may be required.

PAY RANGE:
This position will be filled at the Engineer III or Sr. Engineer level, dependent upon the qualifications and experience of the successful candidate. The annual salary range for the Scientist I-III is $105,000-$140,000.

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk, stoop or crouch

Lifting

• Frequently lift and/or move up to 10 pounds.
• Rarely lift and/or move up to 25 pounds.

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail