Validation Engineer / Validation Specialist

Stark Pharma Solutions Inc; Potomac (MD); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc in Maryland is seeking an experienced Validation Engineer to support IQ/OQ/PQ/RQ for equipment, utilities and process qualification in a GMP environment. You will generate validation reports, develop documentation, and ensure GDP compliance while collaborating with interdisciplinary teams.

The role requires hands-on qualification activities, thermal mapping with Kaye AVS or Veriteq, deviation investigations, and participation in audits.

Qualifications

• Bachelor's degree in Engineering or related field with 4+ years of validation experience (or 8+ without degree).
• Experience in GMP pharmaceutical/biotech manufacturing.
• Hands-on with IQ/OQ/PQ/RQ qualification activities.
• Knowledge of cGMP and GDP.
• Experience with aseptic manufacturing processes.
• Familiarity with thermal mapping systems (Kaye AVS or Veriteq).
• Knowledge of cleanrooms, HVAC, WFI, RO, CCA, isolator tech.
• Experience with MS Office, EDMS, LIMS, and docs systems.
• Strong technical writing, communication, organizational, project mgmt.
• Ability to work independently and cross-functionally.
• Knowledge of maintenance and calibration is preferred.

Responsibilities

• Prepare, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for equipment and utilities.
• Generate qualification reports, SOPs, specifications, methods, and other validation documentation.
• Develop acceptance criteria based on industry standards, manufacturer recommendations, user requirements, and cGMP guidelines.
• Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
• Analyze validation data and verify compliance with acceptance criteria.
• Investigate, document, and resolve deviations associated with qualification studies.
• Support commissioning, FAT, and SAT.
• Prepare technical reports, gap assessments, and risk assessments.
• Provide technical support for troubleshooting manufacturing equipment and systems.
• Perform technical reviews of qualification documents.
• Support internal and external audit readiness activities.

Skills

Validation

IQ/OQ/PQ/RQ

GMP

GDP

Aseptic manufacturing

Thermal mapping

Cleanrooms/HVAC

LIMS/EDMS

Technical writing

Cross-functional collaboration

Maintenance/Calibration

Education

Bachelor's degree in Engineering or related scientific discipline

Tools

Kaye AVS

Veriteq

LIMS

EDMS

Job description

Position: Validation Engineer / Validation Specialist

Location: Maryland

Duration: Long Term

Job Overview

We are seeking an experienced Validation Engineer / Validation Specialist to support equipment, utility, and process qualification activities within a GMP pharmaceutical/biotechnology manufacturing environment. The ideal candidate will prepare and execute IQ, OQ, PQ, and Requalification (RQ) protocols, generate validation reports, develop technical documentation, and ensure compliance with cGMP and Good Documentation Practices (GDP).

Key Responsibilities

• Prepare, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for equipment and utilities.
• Generate qualification reports, SOPs, specifications, methods, and other validation documentation.
• Develop acceptance criteria based on industry standards, manufacturer recommendations, user requirements, and cGMP guidelines.
• Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
• Analyze validation data and verify compliance with acceptance criteria.
• Investigate, document, and resolve deviations associated with qualification studies.
• Support commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Prepare technical reports, gap assessments, and risk assessments.
• Provide technical support for troubleshooting manufacturing equipment and systems.
• Perform technical reviews of qualification documents.
• Support internal and external audit readiness activities.

Required Qualifications

• Bachelor's degree in Engineering or a related scientific discipline with a minimum of 4 years of validation experience, or 8+ years of relevant validation experience in lieu of a degree.
• Experience working in GMP pharmaceutical or biotechnology manufacturing environments.
• Hands‑on experience with Equipment Qualification (IQ/OQ/PQ/RQ) activities.
• Knowledge of cGMP regulations and Good Documentation Practices (GDP).
• Experience with aseptic manufacturing processes.
• Familiarity with Kaye AVS or Veriteq thermal mapping systems.
• Working knowledge of cleanrooms, sterilization equipment, HVAC, WFI, RO, CCA, computerized systems, and isolator technology.
• Experience with Microsoft Office, EDMS, LIMS, and related documentation systems.
• Strong technical writing, communication, organizational, and project management skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Knowledge of maintenance and calibration procedures is preferred.