Validation Engineer / Validation Specialist

Stark Pharma Solutions Inc; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Validation Engineer / Validation Specialist to support qualification activities in a GMP manufacturing setting. The role focuses on preparing and executing IQ/OQ/PQ/RQ protocols, generating validation documents, and ensuring compliance with cGMP and GDP standards.

The ideal candidate will bring hands-on validation experience in biotech or pharmaceutical manufacturing, familiarity with aseptic processing, and proficiency with EDMS, RAM, and

Qualifications

• Bachelor's degree required with 4+ years validation experience or 8+ years without degree.
• Hands-on GMP biotech/pharma validation experience.
• Experience with IQ/OQ/PQ/RQ and GDP/cGMP practices.
• Experience with aseptic processing and cleanroom environments.

Responsibilities

• Prepare and execute IQ/OQ/PQ/RQ protocols and reports for equipment and utilities.
• Develop acceptance criteria based on standards and cGMP requirements.
• Generate validation summary reports following GDP.
• Maintain and revise SOPs related to validation activities.
• Support deviations resolution and technical reviews of docs.

Skills

Validation experience

IQ/OQ/PQ/RQ

cGMP knowledge

GDP knowledge

aseptic processing

Documentation skills

Education

Bachelor's degree in Engineering, Science, or a related field

Tools

Kaye AVS

Veriteq dataloggers

EDMS

RAM

LIMS

Microsoft Office

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 validation activities within a GMP manufacturing facility. The successful candidate will be responsible for preparing and executing qualification protocols, generating validation documentation, supporting equipment and utility validation, and ensuring compliance with cGMP and Good Documentation Practices.

Key Responsibilities

• Prepare and execute IQ/OQ/PQ/RQ protocols and reports for new and existing equipment and utilities.
• Develop acceptance criteria based on industry standards, manufacturer recommendations, user/functional specifications, and current cGMP requirements.
• Generate validation summary reports in accordance with Good Documentation Practices (GDP).
• Perform thermal mapping studies using Kaye AVS or Veriteq dataloggers.
• Develop and revise Standard Operating Procedures (SOPs).
• Analyze validation data and verify compliance with established acceptance criteria.
• Document and support resolution of deviations associated with qualification activities.
• Assist with Commissioning, FAT, and SAT activities as required.
• Prepare technical documentation including validation reports, gap assessments, and risk assessments.
• Provide technical and investigative support for troubleshooting and resolving manufacturing equipment issues.
• Perform technical reviews of qualification and validation documents prepared by other team members.
• Support facility and validation activities related to regulatory and client audits.

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related field.
• Minimum 4 years of applicable validation experience with a bachelor's degree, or 8 years of applicable experience in lieu of a bachelor's degree.
• Hands-on validation experience in GMP biotechnology or pharmaceutical manufacturing environments.
• Experience with IQ/OQ/PQ/RQ qualification activities.
• Strong working knowledge of cGMP and Good Documentation Practices.
• Experience and knowledge of aseptic processing.
• Hands-on experience with sterilization equipment, cleanroom environments, cleaning processes, and critical utilities such as HVAC, WFI, RO, and CCA.
• Knowledge of computerized control systems and isolator technology.
• Experience using Microsoft Office and electronic systems such as EDMS, RAM, and LIMS.
• Strong written and verbal communication skills with excellent attention to detail.
• Ability to manage multiple projects and work effectively both independently and as part of a team.
• General knowledge of maintenance and calibration procedures is desirable.