Manufacturing - CGMP Biomanufactuirng Training Specialist

Medvacon Life Sciences•Madison, WI

2d•Onsite

About The Position

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.

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
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
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

Nice To Haves

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

Responsibilities

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