Process Engineer II

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

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.

• 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

• 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

• The salary range for this position is $85,000-$110,000.

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

• Regularly sit for long periods of time

• 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

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 40 pounds

• Frequently utilize close vision and the ability to adjust focus

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

• 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
• 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

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Locations:
Fishers, Indiana and Lexington, Massachusetts.