Process Engineer II
Genezen•Lexington, MA
•Onsite
About The Position
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.
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
Nice To Haves
- Experience in cell culture, protein purification, or process control systems is desirable
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
Benefits
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
