Location
Framingham, MA | United States
Job description
8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.
Digital Operations Technology (DOT) is responsible for supporting and maintaining all operational technology systems in 8NYA including process control systems (DeltaV), data historian (PI) and manufacturing execution systems (MES).
This is a 12 hour, rotating position in a flexible, single-use technology, large scale
cGMP biologics facility.
The Automation and Manufacturing Systems Support Technician will be responsible for on the floor manufacturing support for DOT systems and supporting infrastructure.
Core Responsibilities
Maintains a safe working environment and reporting of incidents/accidents to Manufacturing and DOT management. Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.
Responds to manufacturing requests for support and troubleshooting of issues related to DOT systems.
Attends Gembas to represent DOT.
Performs and documents automation interventions to support manufacturing when issues arise whilst maintaining strict GxP compliance.
Performs and supports root cause analysis for deviations and issues related to DOT systems.
Proposes, reviews and executes CAPAs and CCRs related to DOT systems.
Provides training and technical explanations to manufacturing. Documents all issues in Sanofi’s incident management system for analysis and resolution by the wider DOT team as required.
Additional Responsibilities
Cross train manufacturing personnel
Continuous Improvement
Contributes to continual improvement of all manufacturing documentation (SOP’s, EWI’s, MBR’s, OJT’s) to ensure they are current, accurate, and clear.
Supports plant floor continuous improvement initiatives with a focus on automation and manufacturing systems.
*Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
BASIC QUALIFICATIONS:
Undergraduate degree in engineering of science related field.
or 1 year experience in supporting manufacturing operational technology systems.
PREFERRED QUALIFICATIONS:
Undergraduate degree in engineering of science related field.
Experience supporting DeltaV, Werum PAS-X, PI Data Historian, Rockwell PLCs, Honeywell EBI.
Experience supporting and troubleshooting instrumentation and control devices, IO wiring and networks
Experience in cGMP manufacturing operations.
SPECIAL WORKING CONDITIONS:
Ability to gown and enter clean rooms.
Ability to stand on average 10 hours per shift.
Ability to gown and gain entry to manufacturing areas.
Ability to work a twelve hour rotating shift and every other weekend, including holidays as scheduled.
Ability to work twelve hour night time shift (night time staff only)
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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