Sr. Facility Engineer

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. 

Job Scope:

Facilities Engineer will work with the Sr. Manager of Engineering, the integrated facility management group, Quality Management and Manufacturing Management on the daily operation of the manufacturing facility, utilities and processing / testing equipment at the Hopewell site. The role will involve review of equipment and system drawings, specifications, and submittals for general constructability, completeness, safety, maintainability, accessibility, operability, and conformance with the applicable codes, regulations, and design intent. Incumbent will ensure regulatory compliance of all inspection requirements; play a major role in end-user support, ongoing development, and support of the CMMS (Computerized Maintenance Management  System). The incumbent must adhere to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Essential responsibilities:

•    Review Equipment and System Drawings, Specifications, and Submittals for general, completeness, safety, maintainability, accessibility, operability, and conformance with the applicable codes, regulations, and design intent
•    Review Change controls and IQOQ/PQ for new equipment onboarding and decommissioning.
•    Troubleshoot, determine root cause of problems and provide optimization strategies for utility systems and equipment within a multi-product, GMP facility.
•    Provide spare parts and reliability analyses for critical components, equipment, and systems
•    Author and or review and approve documentation for QA Change Controls and Quality Events.
•    Serve as subject matter expert of the facilities/utilities/systems to support assigned work orders and close out facility related quality events as applicable
•    Provide project team with utility system engineering design requirements and subject matter expertise.    Communicate project requirements to vendors to obtain proposals for equipment and system . 
•    Manage CMMS System and configuration modules, workflow, development and user administration. 
•    Support and maintain CMMS system reports; run queries and create ad hoc reports to support performance reporting , support compliance metrics and capacity planning.
•    New data entries into CMMS to support work order management and calibration data which includes and not limited to:
o    Configures/adds new users and services as necessary
o    New asset and location creation
o    Job Plan Creation
o    PM creation
o    Data sheets
•    Participates in and, as necessary, actively contributes to, investigator meetings.
•    Process GxP and non-Gxp lab instrument asset status updates (new, retirement, moves, owner changes, computer upgrades, etc.) 
•    Create and revise formal work instruction that documented the standards for managing instruments within the CMMS (i.e. instrument naming conventions, parent / child hierarchical relationships, system owner identification, etc.).
•    Assist in determining the appropriate service interval (frequency) and provider (internal vs. vendor) with owner’s assistance

Compensation: The salary range, dependent upon experience level, range is $80,000 - $110,000 annually.

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GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.