Manufacturing Systems & Master Data Lead

Orcabiosystems

Sacramento (CA)

On-site

USD 120,000 - 180,000

Full time

10 days ago

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Benefits offered by this job

Pre-IPO equity
Annual bonus
Medical, dental, and vision benefits
PTO
401(k) plan
Life and AD&D insurance
Parental leave
Subsidized daily lunches and snacks

Job summary

Orca Bio in Sacramento, CA, seeks a Manager, Manufacturing Systems & Master Data to own MES and related systems, govern master data, and drive GMP-compliant process improvements across manufacturing, inventory, procurement, quality, planning, and commercial ops.

You will lead UAT, define business requirements, maintain material masters, BOMs, vendor records, and ensure data integrity. This role collaborates with IT, Finance, and vendors, with no direct reports and on-site work.

Qualifications

  • Bachelor's degree in Engineering, Supply Chain, Information Systems, or a related discipline.
  • 5+ years of experience in manufacturing systems, ERP/MES administration, manufacturing operations, or master data management.
  • Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or other GMP-regulated environments.
  • Experience serving as a business owner or super user for ERP and/or MES systems.
  • Experience implementing or enhancing ERP/MES solutions in a manufacturing environment.
  • Excellent interpersonal, leadership, and communication skills.
  • Experience with autologous or allogeneic cell therapy supply chains, preferred.
  • Certification in Production and Inventory Management or Logistics (APICS) a plus.

Responsibilities

  • Serve as the business owner / user for ERP, MES, and related manufacturing systems ensuring systems align with operational requirements and GMP compliance.
  • Develop and maintain manufacturing system standards, procedures, and work instructions.
  • Partner with IT and software vendors to resolve system issues and implement improvements.
  • Lead User Acceptance Testing (UAT), business validation activities, and deployment of system upgrades.
  • Develop business requirements and functional specifications for new capabilities and enhancements.
  • Own all material master records within Material Management (ERP/MES) systems.
  • Create and maintain raw materials, consumables, packaging, labels, and finished goods.
  • Create and maintain inventory attributes, storage conditions, shelf life, and lot control parameters.
  • Create and maintain Bills of Materials (BOMs).
  • Maintain manufacturing recipes and packaging configurations (where applicable).
  • Maintain material specifications and approved supplier information.
  • Link release testing requirements and quality specifications to materials.
  • Create and maintain vendor master records in partnership with Procurement.
  • Manage units of measure, conversion factors, and planning parameters.
  • Support engineering changes, change controls, and product introductions.
  • Ensure data integrity and GMP compliance.
  • Coordinate master data changes and system changes across Procurement, Manufacturing, Quality, MSAT, and Supply Chain.

Skills

ERP/MES administration
Master data management
GMP compliance
Manufacturing systems
Supplier/vendor management
UAT testing
Project leadership

Education

Bachelor's degree in Engineering or related field

Tools

ERP systems
MES software
IT collaboration tools

Job description

Orca Bio in Sacramento, CA, seeks a Manager, Manufacturing Systems & Master Data to own MES and related systems, govern master data, and drive GMP-compliant process improvements across manufacturing, inventory, procurement, quality, planning, and commercial ops.

You will lead UAT, define business requirements, maintain material masters, BOMs, vendor records, and ensure data integrity. This role collaborates with IT, Finance, and vendors, with no direct reports and on-site work.

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