Principal Process Engineer, LNP

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

The Principal Process Engineer is responsible for design, construction, commissioning and technical support of process systems at the state-of-the-art cell therapy manufacturing facility being built in Framingham, MA.

The successful candidate will be creative, team oriented and have hands on experience in Engineering support of cGMP manufacturing operations and design of new processes, and a strong grasp process equipment within a multi-product, FDA regulated, cGMP facility. The ideal candidate will participate in all levels of design, startup, and operations including on the floor support of systems and issues. They will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives and will report directly to Head of Process Engineering. 

 Responsibilities

• Design, specification, and selection of single use equipment systems
• Generate system user requirement specifications (URS)
• System SME representative in design reviews 
• Support automation and monitoring systems integration
• Generate facility capacity models and design the development of COGs models
• Provide and delegate technical support of Commissioning & Qualification activities (approval of protocols and reports)
• Technical guidance SME and deliver analysis for the resolution of equipment related deviations and investigations
• Lead implementation of process improvement projects through change control
• Co-author department procedures and specifications

  Minimum Qualifications

• Bachelor of Science Degree in Chemical, Mechanical, or Bio-Engineering with 15+ years of relevant work experience or PhD and 8+ years of experience
• Experience with specification and implementation of single use systems (tangential flow filtration systems a plus)
• Excellent attention to detail and capable of managing multiple priorities with aggressive timelines
• Strong leadership, interpersonal communication skills and ability to work effectively with internal cross functional teams and external partners and vendors
• Proficient at applying good engineering practices, industry guidance, and regulatory requirements
• Creative problem solver and decision maker

Preferred Qualifications

• Experience with Kneat and Blue Mountain CMMS

​Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. 

Principal Process Engineer, LNP: Base pay range of $168,000 to $180,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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