Manufacturing Specialist

Hydrogen Group; Hayward (CA); Presencial; USD 37 000 - 43 000; Tempo integral

Resumo da oferta

Hydrogen Group seeks a Manufacturing Specialist in Hayward, CA to provide technical and process support to meet production plans while ensuring quality and compliance with company systems. The role runs on-site, 6-month contract, with a Mon–Fri 8:00–4:30 schedule and a $27–$31/hr pay rate.

The candidate will analyze production data, collaborate on process improvements, support validation protocols, and act as an SME for MES and eDHR processes, interfacing with IT, Quality, and Process

Qualificações

• No prior technical experience is typically required; detailed instructions are normally provided for all work.
• Strong organizational skills, attention to detail, and accuracy.
• Ability to work independently within a team environment.
• Ability to collaborate with cross-functional teams and manage ambiguity.
• Strong interpersonal, verbal, and written communication skills.
• Excellent troubleshooting skills.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP ERP systems is a plus.
• Hands-on experience with clinical or diagnostic instrumentation, including DNA sequencing instrumentation or equivalent, is highly desirable.

Responsabilidades

• Analyze production data to identify trends and define actions to improve efficiency, product quality, and cost.
• Identify process discrepancies and collaborate with Life Cycle Management and Process Engineering on improvements.
• Support maintenance of the validated state by providing subject matter expertise on validation plans and verification and validation protocols, and executing released protocols.
• Act as a subject matter expert during development and change management for Manufacturing Execution Systems (MES) and electronic Device History Record (eDHR) processes and systems, collaborating with IT, Process Engineering, and Quality.
• Support the development, creation, and modification of quality documents, including work instructions, procedures, process failure mode and effects analyses (pFMEAs), validation test reports, batch record templates, and test methods.
• Participate in continuous improvement teams and projects using Operational Excellence and Lean Six Sigma methodologies.
• Participate in the manufacturing internal audit program and assist with corrective actions and audit responses.
• Test next-generation DNA sequencing instrumentation using released procedures and processes.
• Troubleshoot products and process nonconformances in collaboration with Manufacturing, Quality, and Life Cycle Management.
• Establish and maintain reports of instrument failures and defects.
• Perform other duties as needed.

Conhecimentos

Strong organizational skills

Attention to detail

Independent working within a team

Cross-functional collaboration

Communication skills

Troubleshooting

MS Office (Excel, Word, PowerPoint)

SOPs, DHRs, ECOs, GLP, GMP, SAP ERP

DNA sequencing instrumentation

Formação académica

High school diploma or GED

Bachelor’s degree in Engineering, Chemistry, Biology, or Physics

Ferramentas

SAP ERP systems

Microsoft Office (Excel/Word/PowerPoint)

Descrição da oferta de emprego

Title: Manufacturing Specialist
Location: Hayward, CA — Onsite
Pay: $27.00-$31.00/hr
Schedule: Monday–Friday, 8:00 a.m.–4:30 p.m.
Duration: 6-month contract

Job Summary

Provide technical and process support to the manufacturing team to achieve production plans while maintaining quality and compliance with company quality systems.

Key Responsibilities

• Analyze production data to identify trends and define actions to improve efficiency, product quality, and cost.


• Identify process discrepancies and collaborate with Life Cycle Management and Process Engineering on improvements.


• Support maintenance of the validated state by providing subject matter expertise on validation plans and verification and validation protocols, and executing released protocols.


• Act as a subject matter expert during development and change management for Manufacturing Execution Systems (MES) and electronic Device History Record (eDHR) processes and systems, collaborating with IT, Process Engineering, and Quality.


• Support the development, creation, and modification of quality documents, including work instructions, procedures, process failure mode and effects analyses (pFMEAs), validation test reports, batch record templates, and test methods.


• Participate in continuous improvement teams and projects using Operational Excellence and Lean Six Sigma methodologies.


• Participate in the manufacturing internal audit program and assist with corrective actions and audit responses.


• Test next-generation DNA sequencing instrumentation using released procedures and processes.


• Troubleshoot products and process nonconformances in collaboration with Manufacturing, Quality, and Life Cycle Management.


• Establish and maintain reports of instrument failures and defects.


• Perform other duties as needed.

Required Education

• High school diploma or GED.

Preferred Education

• Relevant college-level STEM coursework or training.


• Bachelor’s degree in Engineering, Chemistry, Biology, or Physics.

Experience and Skills

• No previous technical experience is typically required; detailed instructions are normally provided for all work.


• Strong organizational skills, attention to detail, and accuracy.


• Ability to work independently within a team environment.


• Ability to collaborate with cross-functional teams and manage ambiguity.


• Strong interpersonal, verbal, and written communication skills.


• Excellent troubleshooting skills.


• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.


• Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP ERP systems is a plus.


• Hands-on experience with clinical or diagnostic instrumentation, including DNA sequencing instrumentation or equivalent, is highly desirable.