Validation Engineer

Syner-G•Greenville, NC

1d•Remote

About The Position

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. The Validation Engineer will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements.

Requirements

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

Nice To Haves

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.

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.