Location: Onsite
Duration: 4–6 Month Contract
Schedule: Monday–Friday | 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.
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Organize and present in-person training sessions for the cGMP Biomanufacturing Group
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Deliver training on:
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Standard Operating Procedures (SOPs)
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FDA cGMP requirements
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Environmental Health & Safety (EHS)
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Compliance processes
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Job-specific and general work skills
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Actively lead and facilitate training sessions
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Assist in conducting training needs assessments to identify learning gaps and development requirements
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Work with managers to address employee learning needs, instruction challenges, and educational opportunities
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Develop and administer employee training programs
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Create and revise training manuals and educational materials
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Modify training materials based on evaluation and effectiveness findings
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Develop qualifications and evaluations to measure training effectiveness within Manufacturing
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Track and monitor employee training status and completion
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Maintain accurate and timely training records and compliance metrics
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Provide reports and recommendations to the Training Manager to ensure compliance requirements are met
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Review training documentation for accuracy and completeness
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Support maintenance of the Quality System as it relates to cGMP and training requirements
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Assist the Quality Assurance team with SOP training as needed
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Partner with Subject Matter Experts (SMEs) to identify training needs, target audiences, and performance expectations
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Participate in team meetings and cross-functional initiatives
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Communicate policies, procedures, decisions, and performance-impacting information to personnel
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Support safety initiatives and continuous improvement efforts on the manufacturing floor
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Provide on-the-floor manufacturing support as needed
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Assist with cleanroom housekeeping and adherence to 5S standards
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Support execution of equipment qualification and validation protocols as required
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Perform additional duties as assigned
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Support scheduled and off-shift coverage as business needs require
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Bachelor’s degree (B.S./B.A.) in:
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Biology
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Chemistry
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Or a related scientific discipline
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Minimum of 1–2 years of related laboratory or industry experience
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Biomanufacturing, pharmaceutical, or medical device industry experience
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Experience working in cleanroom environments and/or with aseptic techniques
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General laboratory equipment experience
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Knowledge of:
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Current Good Manufacturing Practices (cGMP)
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Good Documentation Practices (GDP)
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Good Laboratory Practices (GLP)
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Experience following Standard Operating Procedures (SOPs)
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Experience operating, maintaining, and troubleshooting biomanufacturing-related equipment
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Commercial biomanufacturing experience
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Pharmaceutical or medical device manufacturing experience
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Prior ISO 6/7/8 cleanroom experience
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Previous dedicated training or instructional experience
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Experience using:
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TrackWise
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ComplianceWire
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Other electronic learning or compliance tracking systems
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Ability to work within ISO 6/7/8 cleanroom environments
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Proficiency with:
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Microsoft Excel
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Microsoft Word
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Microsoft Office applications
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Ability to perform basic mathematical calculations and verify accuracy of results
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Strong documentation and data review skills
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Ability to peer review documentation and ensure organization and completeness
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Ability to independently apply cGMP principles to daily work activities and equipment use
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Ability to operate within a cleanroom environment and provide manufacturing floor support
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Strong attention to detail and commitment to compliance and quality standards
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to [email protected].
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