Validation Engineer / Validation Specialist

Location: Maryland • Long-term assignment

About the role

We are seeking an experienced Validation Engineer / Validation Specialist to support validation activities within a GMP manufacturing facility. The successful candidate will prepare and execute qualification protocols, generate validation documentation, support equipment and utility validation, and ensure compliance with cGMP and Good Documentation Practices.

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.

Requirements

• 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.

Skills

• General knowledge of maintenance and calibration procedures is desirable.