Manufacturing System Engineer

1 week ago

WinstonSalem, United States Hallmark Global Solutions Ltd Full time

Title: Manufacturing Systems Lead

Location: Winston Salem, NC

Duration: 6+ Months Contract

Note: Onsite/Hybrid at Winston Salem, NC (3-5 days/week)

Role/Responsibilities:

• Lead implementation and support of site GMP manufacturing systems.

• Lead automation of site manufacturing operations.

• Lead implementation of data acquisition and analytics platform in support of site manufacturing.

• Provide Industry 4.0 vision for digitalization of manufacturing.

• Providing day-to-day expertise to manufacturing operations for use of site GMP manufacturing systems.

• Managing vendors to troubleshoot system issues and functionality.

• Escalate and ensure closure of all production issues related manufacturing systems.

• Lead deployment of system patches and upgrades as necessary.

• Partner with business for continuous improvement.

• Lead integration of manufacturing systems with shop-floor equipment and enterprise systems.

• Manage vendor SLA and ensure closure of all issues.

• Partner with stakeholders to ensure system stays in compliance with company and industry regulations including validated state.

• Partner with stakeholders to create and manage system change controls and associate validation activities.

• Partner with vendor and stakeholders to plan enhancements including leveraging new functionality.

Experience:

• Previous experience (5 years plus) with implementation and support of MES/EBRs, Laboratory systems, Calibration Management, Building Management, Warehouse Systems, quality management systems, data historian, data analytics, labeling, barcode scanners, printers, and other devices across manufacturing shop-floor.

• Pharma/Biotech/Cell Therapy Experience Required.

• FDA GMP experience is required.

• Experience with IT Systems Lifecycle.

• Computer Systems Validation Experience.

Regards,

Naveen Kumar– Technical Recruiter | Technology Consulting

Hallmark Global Technologies, Inc. |200 Motor Parkway | Suite D-26 | Hauppauge | NY 11788

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