Manufacturing Associate

Planet Pharma; Hayward (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

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

You will analyze data to drive efficiency and quality, collaborate on process improvements, and serve as SME for validation plans, MES/eDHR changes, and quality document updates. Strong organizational skills and teamwork are essential.

Qualifications

• High school diploma or GED required; STEM coursework a plus.
• Some relevant college-level STEM courses or training are preferred.
• Bachelor's degree in Engineering, Chemistry, Biology or Physics is preferred.

Responsibilities

• Analyze production data to identify trends and drive efficiency, quality, and cost improvements.
• Collaborate with LCM and Process Engineering to resolve process discrepancies.
• Provide SME support on Validation plans, verification and validation protocols, and released protocols.
• Act as SME during development and change management on MES and eDHR processes and systems with GIS, Process Engineering and Quality.
• Assist in creating or updating Quality Documents such as work instructions, procedures, pfMEAs, validation test reports, batch records, and test methods.
• Participate in continuous improvement projects using Operational Excellence and Lean Six Sigma tools.
• Support internal manufacturing audits and assist with corrective actions and responses.
• Test next-gen DNA sequencing instrumentation using released procedures.
• Troubleshoot product non-conformances with Manufacturing, Quality, and LCM.
• Establish and maintain reports on instrument failures and defects.

Skills

Analytical thinking

Attention to detail

Team collaboration

Communication skills

Education

High school diploma or GED

STEM coursework or training

Bachelor's degree in Engineering/Chemistry/Biology/Physics

Tools

Microsoft Office (Excel, Word, PowerPoint)

SAP ERP systems

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 to Quality 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.
• 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.