Validation Specialist

Lancesoft; Fort Washington (Montgomery County); On-site; USD 65,000 - 85,000; Full time

Job summary

Lancesoft is seeking a Validation Specialist 2 to provide testing, sampling, inspection, and technical support within the Quality Assurance department for the logistics area. The role acts as a SME for sampling and inspection of chemical components, bulk products, containers and closures, labeling, and packaging materials to ensure GMP and safety compliance.

The candidate will perform sampling/inspection, prepare samples for lab testing, and mentor staff while supporting audits, process

Qualifications

• High School Diploma or equivalent required.
• Minimum 4 years of experience in a pharmaceutical and/or OTC manufacturing environment.
• Warehousing and inventory control system experience required.
• Sampling and inspection experience in a pharmaceutical and/or OTC environment preferred.
• Strong GMP knowledge and compliance focus.

Responsibilities

• Perform sampling and inspection of: Chemical components; Bulk products; Containers and closures; Labeling and packaging materials.
• Prepare, label, and deliver samples to the laboratory for testing.
• Train and mentor sampling and inspection personnel.
• Support audits, regulatory inspections, and audit observation resolution.
• Assist with SOP revisions, process improvements, and continuous improvement initiatives.
• Track packaging component inspection and annual testing requirements.
• Maintain accurate GMP documentation and records.
• Participate in investigations and quality-related activities.

Skills

GMP knowledge

Interpersonal skills

Teamwork

Basic computer proficiency

Education

High School Diploma or equivalent

Tools

SAP

LIMS

Microsoft Excel

MS Office

ERP systems

Electronic batch records

Job description

Title: Validation Specialist 2

Location: Fort Washington PA 19034

Duration: 11/09/2026 to 02/04/2028

Position Summary

The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area. The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements.

Key Responsibilities

• Perform sampling and inspection of: Chemical components
• Bulk products
• Containers and closures
• Labeling and packaging materials
• Support packaging material review and disposition activities.
• Prepare, label, and deliver samples to the laboratory for testing.
• Train and mentor sampling and inspection personnel.
• Support audits, regulatory inspections, and audit observation resolution.
• Assist with SOP revisions, process improvements, and continuous improvement initiatives.
• Track packaging component inspection and annual testing requirements.
• Maintain accurate GMP documentation and records.
• Participate in investigations and quality-related activities.
• Support safety, environmental, and compliance programs.

Required Systems/Technical Skills

• SAP LIMS Microsoft Excel MS Office applications ERP systems Electronic batch records and automated quality systems experience preferred

Required Qualifications

• High School Diploma or equivalent required.
• Minimum 4 years of experience in a pharmaceutical and/or OTC manufacturing environment.
• Warehousing and inventory control system experience required.
• Sampling and inspection experience in a pharmaceutical and/or OTC environment preferred.
• Strong GMP knowledge and compliance focus.
• Ability to work effectively with all levels of the organization.
• Strong interpersonal and teamwork skills.
• Basic computer proficiency.

Preferred Experience

• Pharmaceutical/OTC sampling and inspection.
• Quality Assurance or Quality Control support.
• Packaging component inspection.
• Continuous improvement, Lean, and process excellence initiatives.