Manufacturing Specialist 1

Planet Pharma; Hayward (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a dedicated professional to provide technical and process support for the manufacturing team in Hayward, CA. The role focuses on ensuring production plans are met while upholding quality and compliance with Quality Systems.

You will analyze production data to drive improvements, support validation activities, and collaborate across quality, process engineering, and MES/eDHR systems.

Qualifications

• Strong organizational skills with attention to detail and the ability to work independently in a team environment.
• Experience with SOPs, DHRs, ECOs, GLP, GMP is a plus.
• Hands-on experience with clinical/diagnostic instrumentation including DNA sequencing or equivalent is highly desirable.

Responsibilities

• Analyze production data to identify trends and define actions to improve efficiency, quality and cost.
• Identify process discrepancies and collaborate with LCM and Process Engineering for improvement.
• Support maintaining the validated state by providing SME support on Validation plans, verification and validation protocols and executing on released protocols.
• Act as SME during development and change management on MES and eDHR processes and systems by collaborating with GIS, Process Engineering and Quality.
• Assist in developing and, in some cases, creating or modifying Quality Documents such as work instructions, procedures, pFMEA, validation test reports, batch record templates and test methods.
• Participate in continuous improvement projects using Operational Excellence and Lean Six Sigma methodologies.
• Support internal audits and assist with corrective actions and audit responses.
• Test next generation DNA sequencing instrumentation using released procedures and processes.
• Troubleshoot and address non-conformances of products with Manufacturing, Quality and Life Cycle Management.
• Establish and maintain reports of instrument failures and defects.

Skills

Analytical thinking

Troubleshooting

Communication skills

Team collaboration

Attention to detail

MS Office proficiency

Education

High School Diploma or GED

Bachelor's degree in Engineering/Science (e.g., Engineering, Chemistry, Biology, Physics)

Tools

SAP ERP systems

Microsoft Office (Excel, Word, PowerPoint)

Job description

Job Summary:

Responsible for technical and process support to the manufacturing team in order to effectively achieve production plans while maintaining quality and compliance toQuality Systems

Tasks and responsibilities:

• Analyze production data to determine trends and define actions to improve efficiency, product quality and cost.
• Identify process discrepancies and collaborate with LCM and Process Engineering for improvement.
• Support maintaining the validated state by providing SME support on Validation plans, verification and validation protocols and executing on released protocols.
• Act as SME during development and change management on MES and eDHR process and systems by collaborating with GIS, Process Engineering and Quality.
• Support development and in some cases create or modify Quality Documents such as; work instructions, procedures, pFMEA’s validation test reports, batch record templates and test methods.
• Proactively participate on continuous improvement teams and projects using techniques from Operational Excellence and Lean Six Sigma methodologies.
• Participate in manufacturing internal audit program and assist with corrective actions and audit responses.
• Test next generation DNA sequencing instrumentation using released procedures and processes.
• Troubleshoot and process non-conformances of products while collaborating with Manufacturing, Quality and Life Cycle Management.
• Establish and maintain reports of instrument failures and defects.
• Other duties as needed.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Required educational background:

• High school diploma, GED.
• Some relevant college level STEM courses or training are a plus.

Preferred educational background:

• Bachelors (BA/BS) in Engineering, Chemistry, Biology, Physics.

Preferred experiential background:

• Typically requires no previous technical experience.
• Normally receives detailed instructions on all work.
• Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
• Ability to collaborate on multifunctional teams and manage ambiguity.
• Strong interpersonal, verbal and written communication skills.
• Excellent troubleshooting skills required.
• Proficiency with Microsoft Office Tools (Excel, Word, and PowerPoint)
• Experience with SOPs, DHRs, ECOs, GLP, GMP and SAP ERP systems is a plus.
• Hands on experience with clinical/diagnostic instrumentation including DNA sequencing or equivalent is highly desirable.