Manufacturing Automation Engineer (MES)
Company: CRISPR Therapeutics AG
Posted on: June 7, 2021
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.
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
- 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
- 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
- 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
- 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
- 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
- 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
- Bachelor's in Life Sciences, Engineering, Computer Science, or
- Minimum of 5 years' experience in pharmaceuticals
manufacturing. Minimum 3 years specialist experience
- 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
- 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
- Ability to make decisions and work with minimal to moderate
- Able to provide effective written or verbal communication to
peers, senior associates, and area management within their
- 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:
Keywords: CRISPR Therapeutics AG, Framingham , Manufacturing Automation Engineer (MES), Other , Framingham, Massachusetts
Didn't find what you're looking for? Search again!