Jenna Eicherly

About Jenna Eicherly

High performer with experience in Project Management, Validation, and Quality Engineering arenas in the medical device, pharmaceutical, and biopharmaceutical industries. Strong knowledge in FDA and ISO regulatory requirements. Experience leading and managing teams of direct reports. Project Management areas of expertise include: creating project plans, tracking project completion against the plan, and negotiating for additional resources. Validation areas of expertise include: cleaning validation, sterilization validation, process validation, controlled temperature qualifications, equipment qualifications. Experience with lyophilizers. Quality Engineering responsibilities have included CAPAs, internal auditing, supplier auditing, nonconformance investigations into root cause, managing facility compliance programs, auditing procedures for compliance, and authoring guidance documents (i.e. SOPs). Strong in both study execution and validation documentation (protocols, reports, etc.). Strong ability to develop top-quality documentation. Consistently recognized for ability to develop strong relationships with customers.Specialties: • Project management.• Cleaning Validation.• FDA and ISO regulatory requirements.• CAPA management.• Internal auditing.• Supplier auditing.• Back room support for regulatory audits (FDA, DEKRA, ANVISA, etc.).• Root cause investigations including identifying corrective actions.• Manufacturing investigations.• SOPs.• Compliance.• Steam sterilization validation (particularly autoclaves).• Controlled temperature unit qualifications.• Equipment qualifications.• Process validation.

Experience

1. Senior Manager, Qa Sterilization

   West Pharmaceutical Services

   Sep 2025 — Present

Education

• SP Industries

  Fundamentals II: Advanced Freeze Dryer Operation and Maintenance

• SP Industries

  Fundamentals I: Basic Freeze Dryer (Lyophilizer) Operation and Maintenance

• Juniata College

  BS, Biology

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Compliance
• 21 Cfr
• Vaccines
• Nonconformances
• Cleaning Validation
• Program Management
• Pharmaceutics
• Medical Devices
• Capa
• Change Control
• Glp
• Bioburden
• Iso 13485
• Private Investigations
• Gmp
• Quality System
• Quality Systems
• V&V
• Lyophilization
• Communication and Relationship Building
• Trackwise
• Deviations
• 21 Cfr Part 11
• Corrective and Preventive Action (Capa)
• Iopq
• Sterilization
• Autoclave
• Equipment Validation
• Computer System Validation
• Quality Assurance
• Protocols
• Iso 14971
• Validation
• Sops
• Biopharmaceuticals
• Fda Gmp
• Protocol