Automation Engineer, GMP Position Available In Mercer, New Jersey

Job Description:

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 businessesencompass four major categories based on its leading gene synthesistechnology, including operation as a Life Science CRO, enzyme andsynthetic biology products, biologics development andmanufacturing, and cell therapy. GenScript is committed to strivingtowards its vision of being the most reliable biotech company inthe world to make humans and nature healthier throughbiotechnology. About ProBio ProBio proactively provides end-to-endCDMO service from drug discovery to commercialization withproactive strategies, professional solutions and efficientprocesses in cell and gene therapy, vaccine, biologics discoveryand antibody protein drug to accelerate drug development forcustomers. ProBio’s total cell and gene therapy solution covers CMCof plasmid and virus for IND filing as well as clinicalmanufacturing and commercial manufacturing.

Job Scope:

TheAutomation Engineer is responsible for administration andmanagement of the site’s automation systems, including SupervisoryControl and Data Acquisition (SCADA) system, PLCs, notificationsystems and computerized QC Lab instruments. The scope of theresponsibilities includes the initial installation, ongoingmaintenance, periodic back-up, change control, validation, andretirement of systems. The incumbent works cross-functionally withinternal departments including Information Technology,Manufacturing, Facilities & Engineering, Quality Control, andQuality Assurance, as well as external resources/vendors tomaintain the site’s automation systems. The incumbent supportsadherence to relevant regulatory requirements and company StandardOperating Procedures (SOPs) as appropriate.

Responsibilities:

• Work closely with stakeholders to understand and fulfill systemrequirements and improve the quality of automated processes.
• Collaborate with stakeholders, including Area Managers, SystemOwners, and System Users to ensure successful onboarding, use andretirement of automation systems.
• Develop appropriate ValidationProtocols, Reports, and Lifecycle documents.
• Execute ValidationProtocols and collecting test evidence.
• Create and improveAdministration SOPs of automation systems
• Monitor integrity,availability, performance and operability of automation systems.
• Identify, investigate and correct technical issues, includingperforming root cause analysis for production errors.
• Makeadjustments, enhancements and applying patches or upgrades asrequired for automation systems, while adhering to the ChangeControl process.
• Understand network operations, systemoperations, and Cloud-based systems.
• Administer user accessmanagement.
• Ensure compliance with applicable regulatorystandards.
• Maintain up-to-date knowledge of current technologytrends, programming languages, and automation best practices forbioprocess equipment including single-use bioreactors,chromatography controllers, ultrafiltration skids, and QCinstruments.
• Author appropriate Change Controls and Test Scriptsand serve as the Subject Matter Expert for applicable technicalchanges in automation systems.
• Recommend and integrate newbioprocess equipment and Process Analytical Technologies (PAT).
• Liaison with Business, Quality Assurance, Managed Services, and ITto coordinate the Change Request processes

Training:

c

GxPApplicable Corporate and Departmental Directives, Policies, andProcedures Good Manufacturing Practices and Good DocumentationPractices Automation Control and Data Acquisition EHSLab/Biological Safety Gowning Qualifications:

Bachelor of Sciencein Electrical Engineering, Computer Science, IT, Engineering, orrelated field of study with at least 5-7years of related experiencethat provides direct scientific knowledge of automation systemsoperation and validation principles for computerized biologicsproduction systems. Proven experience as an IT Automation Engineeror similar role. Direct knowledge of the biologics processequipment, SCADA/control systems, and supporting IT networkinginfrastructure. Expertise in scientific / technical subject areas -Equipment Qualification, Computer System Validation, SCADA systemarchitecture, Biotech Process Equipment/Systems. Proficient in useof electronic systems, such as Microsoft Office, variousspecialized software including process documentation Veeva Vault,Material Management (SAP), Computerized Maintenance ManagementSystem (Maximo), Building Automation System (BAS). Knowledge ofdomestic / international regulatory guidelines / compendia andindustry standards (FDA, ICH, USP and EMEA guidelines) forvalidation of computerized equipment and automation systems,including but not limited to 21 CFR Part 11, EU Eudralex Annex 11and GAMP 5. Expertise in IT Networking and industrial automationsystems, such as Rockwell Automation (Allen Bradley RS Logix),Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicornsoftware, DeltaV, various Repligen and Thermo Scientificinstruments is a plus. Analytical thinker with excellentproblem-solving skills and the ability to adapt to changingpriorities and deadlines. Comfort with collaboration, opencommunication, reaching across functional borders and beingproactive. A strong focus on business outcomes. Ability toprioritize and juggle multiple concurrent projects and day-to-dayrequests Please note that this role is based fully onsite inPennington, New Jersey. The estimated salary range is $90,000 -$120,000 annually. PB LW GenScript USA Inc/ProBio Inc. is a proudequal opportunity/affirmative action employer committed toattracting, retaining, and maximizing the performance of a diverseand inclusive workforce. It is the Company’s policy to ensure equalemployment opportunity without discrimination or harassment basedon race, color, religion, sex (including pregnancy, childbirth, orrelated medical conditions), sexual orientation, gender identity orexpression, age, disability, national origin, marital ordomestic/civil partnership status, genetic information, citizenshipstatus, uniformed service member or veteran status, or any othercharacteristic protected by law. GenScript USA Inc./ProBio Inc.maintains a drug-free workplace.

Please note:

Genscript USAInc./ProBio Inc. will only contact candidates through verifiedapplication sources. GenScript/Probio does not request personalinformation from candidates through individual email or any otherplatform.