Manufacturing - CGMP Biomanufactuirng Training Specialist

Location: Onsite

Duration: 4–6 Month Contract

Schedule: Monday–Friday | 8:00 AM – 5:00 PM

Position Overview

We are seeking a Training Specialist to support the cGMP Biomanufacturing team through the coordination, development, and delivery of training programs. This individual will partner closely with the Training Manager and cross-functional teams to organize and present in-person training related to SOPs, cGMP processes, compliance, and Environmental Health & Safety (EHS).

The ideal candidate will assist with training content development, employee learning initiatives, compliance tracking, and manufacturing floor support while helping maintain training effectiveness and quality system compliance.

Key Responsibilities

Training Coordination & Delivery

• Organize and present in-person training sessions for the cGMP Biomanufacturing Group
• Deliver training on:
• Standard Operating Procedures (SOPs)
• FDA cGMP requirements
• Environmental Health & Safety (EHS)
• Compliance processes
• Job-specific and general work skills
• Actively lead and facilitate training sessions
• Assist in conducting training needs assessments to identify learning gaps and development requirements
• Work with managers to address employee learning needs, instruction challenges, and educational opportunities
• Develop and administer employee training programs
• Create and revise training manuals and educational materials
• Modify training materials based on evaluation and effectiveness findings
• Develop qualifications and evaluations to measure training effectiveness within Manufacturing

Compliance & Training Records

• Track and monitor employee training status and completion
• Maintain accurate and timely training records and compliance metrics
• Provide reports and recommendations to the Training Manager to ensure compliance requirements are met
• Review training documentation for accuracy and completeness
• Support maintenance of the Quality System as it relates to cGMP and training requirements
• Assist the Quality Assurance team with SOP training as needed

Cross-Functional Collaboration & Manufacturing Support

• Partner with Subject Matter Experts (SMEs) to identify training needs, target audiences, and performance expectations
• Participate in team meetings and cross-functional initiatives
• Communicate policies, procedures, decisions, and performance-impacting information to personnel
• Support safety initiatives and continuous improvement efforts on the manufacturing floor
• Provide on-the-floor manufacturing support as needed
• Assist with cleanroom housekeeping and adherence to 5S standards
• Support execution of equipment qualification and validation protocols as required
• Perform additional duties as assigned
• Support scheduled and off-shift coverage as business needs require

Education Requirements

• Bachelor’s degree (B.S./B.A.) in:
• Biology
• Chemistry
• Or a related scientific discipline
• Minimum of 1–2 years of related laboratory or industry experience

Required Qualifications

• Biomanufacturing, pharmaceutical, or medical device industry experience
• Experience working in cleanroom environments and/or with aseptic techniques
• General laboratory equipment experience
• Knowledge of:
• Current Good Manufacturing Practices (cGMP)
• Good Documentation Practices (GDP)
• Good Laboratory Practices (GLP)
• Experience following Standard Operating Procedures (SOPs)
• Experience operating, maintaining, and troubleshooting biomanufacturing-related equipment

Preferred Qualifications

• Commercial biomanufacturing experience
• Pharmaceutical or medical device manufacturing experience
• Prior ISO 6/7/8 cleanroom experience
• Previous dedicated training or instructional experience
• Experience using:
• TrackWise
• ComplianceWire
• Other electronic learning or compliance tracking systems

Technical Skills & Requirements

• Ability to work within ISO 6/7/8 cleanroom environments
• Proficiency with:
• Microsoft Excel
• Microsoft Word
• Microsoft Office applications
• Ability to perform basic mathematical calculations and verify accuracy of results
• Strong documentation and data review skills
• Ability to peer review documentation and ensure organization and completeness
• Ability to independently apply cGMP principles to daily work activities and equipment use
• Ability to operate within a cleanroom environment and provide manufacturing floor support
• Strong attention to detail and commitment to compliance and quality standards