The Process Engineer II plays a key role in supporting 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 small projects.
JOB RESPONSIBILITIES:
- Provides operational support to development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD
- Supports specification, design, testing, and implementation of single use manufacturing systems
- Works on problems where analysis of data requires evaluation of numerous factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions
- Supports projects to modify/improve equipment, facilities and/or process controls with little supervisory oversight
- Provides technical support and analysis for the resolution of deviations, investigations, and process issues
- Develops department procedures and specifications
- Other duties as assigned
JOB REQUIREMENTS:
- BS in Chemical or Mechanical Engineering
- 3-5 years of relevant working experience in a comparable position (similar type of work, similar group dynamics)
- Must be able to communicate effectively in writing and orally across the organization and at multiple levels
- Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities
- Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables
- Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations
- Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring
- Experience in cell culture, protein purification, or process control systems is desirable
COMPENSATION:
- The salary range for this position is $85,000-$110,000.
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 and sit; use hands; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 40 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