GMP QC Equipment Validation Specialist

Lancesoft; Maryland; On-site; USD 83,000 - 124,000; Full time

Job summary

Lancesoft in the United States, Maryland, seeks an experienced Validation Engineer to lead GMP QC lab equipment qualification, temperature mapping, and CSV/CSA activities. The role requires IQ/OQ/PQ execution, strong documentation, and compliance with GMP standards in a fast-paced QC lab setting.

The ideal candidate will develop and review validation documentation, perform temperature mapping studies, and ensure accurate, audit-ready records while collaborating with QA, Engineering, and

Qualifications

• Hands-on GMP QC lab equipment qualification experience.
• Experience with temperature mapping in regulated labs.
• Proficient in IQ/OQ/PQ protocols and final reports.
• Knowledge of SIA/CLRA, CSV and CSA activities.
• Experience with validation docs, deviation management, GMP.
• Understanding data integrity within pharma quality systems.
• Strong technical writing and communication skills.
• Able to work independently in fast-paced projects.

Responsibilities

• Execute IQ/OQ/PQ protocols for GMPQC equipment.
• Conduct temperature mapping studies, plan, execute, collect data and document results.
• Support SIA/CLRA activities and prepare related qualification documents.
• Support CSV and CSA activities as applicable.
• Develop, review and execute validation protocols, scripts and qualification docs.
• Prepare and finalize equipment qualification reports with acceptance criteria.
• Investigate deviations and discrepancies and document resolutions.
• Ensure activities comply with GMP, SOPs, data integrity and regulatory expectations.
• Collaborate with QC, QA, Engineering and cross-functional teams to meet schedules.
• Maintain audit-ready validation documentation.

Skills

GMP compliance

Temperature mapping

IQ/OQ/PQ

SIA/CLRA

CSV/CSA

Data integrity

Technical writing

Independent work

Job description

Lancesoft in the United States, Maryland, seeks an experienced Validation Engineer to lead GMP QC lab equipment qualification, temperature mapping, and CSV/CSA activities. The role requires IQ/OQ/PQ execution, strong documentation, and compliance with GMP standards in a fast-paced QC lab setting.

The ideal candidate will develop and review validation documentation, perform temperature mapping studies, and ensure accurate, audit-ready records while collaborating with QA, Engineering, and