Validation Engineer

Position Overview:

We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures.

Key Responsibilities:

• Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
• Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
• Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
• Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
• Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
• Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
• Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
• Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
• Prepare validation summary reports and support qualification and requalification activities.
• Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
• Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
• Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
• Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
• Maintain validation documentation in accordance with quality system requirements and document control procedures.

Qualifications and Requirements:

Education

• Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.

Technical Experience

• 4-7 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
• Experience supporting equipment qualification, computerized systems validation (CSV), process validation, or automation system validation activities.
• Experience authoring and executing validation documentation, including IQ, OQ, PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
• Experience supporting validation activities for MES, eBR, or manufacturing automation systems is preferred.
• Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar manufacturing systems is preferred.
• Experience supporting audits, inspections, deviation investigations, CAPAs, and change controls is preferred.

Knowledge, Skills, and Abilities

• Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
• Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
• Strong technical writing and documentation skills with attention to detail.
• Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
• Strong organizational, analytical, and problem-solving abilities.
• Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
• Ability to manage multiple assignments and priorities in a fast-paced project environment.
• Working knowledge of validation lifecycle deliverables and quality system processes.
• Ability to work independently while contributing effectively within cross-functional teams.