Manufacturing CGMP Biomanufactuirng Training Specialist

Location: Onsite
Duration: 46 Month Contract
Schedule: MondayFriday 8:00 AM 5:00 PM

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.

• 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

• 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

• 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

• Bachelors degree (B.S./B.A.) in:
  • Biology
  • Chemistry
  • Or a related scientific discipline
• Minimum of 12 years of related laboratory or industry experience

• 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

• 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

• 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

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