Manufacturing Trainer

BioTalent; Tustin (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

BioTalent seeks a Manufacturing Trainer to support GMP manufacturing across Upstream, Downstream, and Formulation, focusing on training, qualification, onboarding, and compliance in a regulated biopharmaceutical setting.

The role develops technical capabilities, maintains documentation standards, and supports continuous improvement initiatives with floor coaching and KPI tracking.

Qualifications

• 1-3 years of GMP manufacturing, operations, training, or related experience.
• Strong understanding of GMP, GDP, and ALCOA+ principles.
• Experience delivering training, coaching, or employee development programs.

Responsibilities

• Deliver classroom, virtual, and hands-on training for manufacturing operations across Upstream, Downstream, and Formulation.
• Facilitate on-the-job training (OJT) and employee qualification activities.
• Support new hire onboarding and employee competency development programs.
• Develop and maintain training materials, SOP-based modules, assessments, and job aids.
• Ensure training content remains aligned with current processes and regulatory requirements.
• Maintain accurate training records and support compliance-related training activities.
• Reinforce GMP, GDP, and ALCOA+ documentation standards.
• Provide floor support, coaching, and guidance to manufacturing personnel.
• Track training metrics, qualification progress, and compliance KPIs.
• Partner with Manufacturing, Quality Assurance, HR, and subject matter experts to support employee development and operational excellence.

Skills

GMP knowledge

Training delivery

OJT/qualification programs

Job description

We are partnering with a leading biologics CDMO seeking a Manufacturing Trainer to support GMP manufacturing operations across Upstream, Downstream, and Formulation. This role focuses on employee training, qualification, onboarding, and compliance, ensuring manufacturing personnel are properly trained and equipped to perform safely and effectively in a regulated biopharmaceutical environment. The Manufacturing Trainer serves as a key resource for developing technical capabilities, reinforcing documentation standards, and supporting continuous improvement initiatives.

Key Responsibilities

• Deliver classroom, virtual, and hands-on training for manufacturing operations across Upstream, Downstream, and Formulation.
• Facilitate on-the-job training (OJT) and employee qualification activities.
• Support new hire onboarding and employee competency development programs.
• Develop and maintain training materials, SOP-based modules, assessments, and job aids.
• Ensure training content remains aligned with current processes and regulatory requirements.
• Maintain accurate training records and support compliance-related training activities.
• Reinforce GMP, GDP, and ALCOA+ documentation standards.
• Provide floor support, coaching, and guidance to manufacturing personnel.
• Track training metrics, qualification progress, and compliance KPIs.
• Partner with Manufacturing, Quality Assurance, HR, and subject matter experts to support employee development and operational excellence.

Qualifications & Requirements

• 1-3 years of GMP manufacturing, operations, training, or related experience.
• Strong understanding of GMP, GDP, and ALCOA+ principles.
• Experience delivering training, coaching, or employee development programs.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.