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Manufacturing Automation Engineer (MES)

Company: CRISPR Therapeutics AG
Location: Framingham
Posted on: June 7, 2021

Job Description:

Company Overview

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Job Summary

The Manufacturing Automation (MES) Engineer responsible for Manufacturing Execution System (MES) engineering support related to SCADA and associated interfaces. The MES Engineer will be a part of the automation team and will work closely with the operations and supply chain teams to deliver and support MES solutions at CRISPR's new state-of-the-art manufacturing facility. This position reports to the Director of Manufacturing IT

Responsibilities

  • Perform MES application administration for Sandbox, Development, Test and Production environments.
  • Configure Master Data as directed by Manufacturing and MS&T such as material master, BOM configurations and Electronic Batch Record (eBR)/electronic Logbook (eLog) creation.
  • Ability to write and maintain GMP system documents such as Standard Operator Procedures (SOP's), Installation/Operational Qualification (IOQ's), Functional Specifications (FS's), and Configuration Specifications (CS's).
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards.
  • Ability to convert business requirements in functional electronic workflows.
  • This position interacts with external organizations, consultants and vendors as required in the successful accomplishment of project assignments.
  • Participate in validation activities in combination with Validation and Quality departments.
  • Ability and desire to learn existing automation systems to provide redundancy and backup to the automation team.
  • Support development of new electronic batch records (eBRs) and revising existing eBRs using a library of work instructions and operations.
  • Create new electronic workflows as assigned. Participates/lead end-user testing requirements and incorporate identified changes from recipe review processes.
  • Team with Manufacturing, Automation, and project teams to schedule and maintain electronic record readiness through each phase of the implementation and sustainability plan.
  • Assist in the execution of Process Change Controls and responses to CAPAs (Corrective and Preventative Actions).
  • Conduct troubleshooting on eBRs and MES development environment.
  • Support the approval and roll out of new/revised SOPs and Functional Specifications as part of paper BRs to eBRs conversion and any ongoing process improvements.
  • Off-hour's coverage and support responsibility via a defined support schedule.
  • Create, assign, perform, and maintain training for manufacturing staff, for MES systems.
  • Edit cGMP documents and process through workflow for the creation of quality approved documentation. Cross-functional collaboration with document control and other supporting groups is required.
  • Support training for manufacturing staff, for MES systems.
  • Support and develop consistent manufacturing standards for recipes used within cGMP manufacturing.
  • Own and maintain tracking systems of MES revisions and priorities.

Qualifications

  • Bachelor's in Life Sciences, Engineering, Computer Science, or Masters preferred
  • Minimum of 5 years' experience in pharmaceuticals manufacturing. Minimum 3 years specialist experience preferred.
  • Experience with Manufacturing Execution Systems (MES) and automated systems required.
  • Background in implementing or software engineering for MES systems (ex.- weigh and dispense, EBR, integration), preferably in a regulated or pharmaceutical production environment preferred.
  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
  • Strong planning, organization and multitasking skills
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
  • Solid understanding of applicable regulatory requirements.
  • Gown aseptically and/or sterile gown as needed.
  • Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  • Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.

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

Keywords: CRISPR Therapeutics AG, Framingham , Manufacturing Automation Engineer (MES), Other , Framingham, Massachusetts

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