Associate Director, Automation Engineering (Engineering)
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, and business offices in London, United Kingdom.
Position Summary
The Associate Director of Automation Engineering will be responsible for operational support, expansion, and continuous improvement of the 33 New York Ave, Framingham, MA manufacturing facility computerized systems, primarily, Rockwell PlantPx for critical utility monitoring and Delta Controls Entelliweb for building management control and monitoring. This role will report to the Head of Engineering/Validation and work closely with IT Infrastructure and IT Compliance to ensure reliability and compliance with 21CFR part 11 requirements.
Responsibilities
- Directs internal and external resources to maintain and drive improvement of computerized systems including Rockwell PlantPx, Delta Controls Entelliweb, and process and analytical equipment.
- Responsible for system administration of computerized process and analytical equipment and all required activities associated to maintain compliance.
- Lead development and achievement of site long range digital technology plan.
- Ensure that computerized systems are in good standing for Regulatory Agency Inspections.
- Create, own, and maintain any identified gaps in policies and procedures.
Minimum Qualifications
- Bachelor's degree (engineering or other relevant discipline preferred)
- 12+ years in the Pharma/Biopharmaceutical industry in Automation/Digital engineering function in support of a GMP-compliant manufacturing environment
- 4+ years managing internal and/or external resources
- Excellent interpersonal, verbal and written communication skills
- Process-oriented with strong analytical skills for risk identification and management
- Excellent organizational and time management skills; experienced in setting priorities and meeting deadlines in a fast-paced environment with changing priorities while maintaining attention to detail; project management experience desired
- Experience with Rockwell PlantPx is strongly preferred
- Experience with using KNEAT for validation
Competencies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
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.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
