Validation Engineer

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

Duration

Approximately 3 Months (Possibility of Extension)

Project Type

Contract

Job Summary

We are seeking an experienced Validation Engineer with strong hands‑on experience in GMP pharmaceutical QC laboratory equipment qualification and temperature mapping. The ideal candidate will be responsible for executing equipment qualification activities, developing and reviewing validation documentation, and ensuring compliance with applicable Good Manufacturing Practice (GMP) requirements and industry standards. The role requires practical experience in Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), temperature mapping, and computerized system validation within a pharmaceutical Quality Control (QC) laboratory environment.

Key Responsibilities

• Execute IQ/OQ/PQ protocols for pharmaceutical QC laboratory equipment in accordance with approved procedures and GMP requirements.
• Perform temperature mapping studies for laboratory equipment, including planning, execution, data collection, analysis, and documentation.
• Support SIA/CLRA activities and prepare associated qualification and assessment documentation.
• Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities, as applicable.
• Develop, review, and execute validation protocols, test scripts, and qualification documents.
• Prepare and finalize equipment qualification reports, ensuring all acceptance criteria are met and deviations are appropriately documented.
• Investigate, document, and support the resolution of deviations, discrepancies, and out-of-specification results encountered during qualification activities.
• Ensure validation activities comply with GMP regulations, approved SOPs, data integrity requirements, and applicable regulatory expectations.
• Collaborate with QC laboratory personnel, Quality Assurance (QA), Engineering, and other cross‑functional teams to complete qualification activities on schedule.
• Maintain accurate, complete, and audit‑ready validation documentation.

Required Qualifications

• Demonstrated hands‑on experience in GMP pharmaceutical QC laboratory equipment qualification.
• Strong practical experience with temperature mapping studies in a pharmaceutical or regulated laboratory environment.
• Proven experience executing IQ/OQ/PQ protocols and preparing final qualification reports.
• Working knowledge of SIA/CLRA, CSV, and CSA activities.
• Experience with validation documentation, deviation management, and GMP compliance.
• Understanding of data integrity principles and pharmaceutical quality systems.
• Strong technical writing, documentation, troubleshooting, and communication skills.
• Ability to work independently and execute qualification activities in a fast‑paced project environment.

Preferred Qualifications

• Experience supporting pharmaceutical QC laboratory equipment commissioning and qualification projects.
• Familiarity with applicable FDA regulations, GxP requirements, and relevant industry guidelines.
• Experience working with cross‑functional teams in pharmaceutical manufacturing, laboratory, or quality environments.
• Availability to work on‑site in Harmans, Maryland, as required.