Validation Engineer

BioSpace; Greenville (NC); On-site; USD 85,000 - 130,000; Full time

Job summary

Syner-G is seeking a Validation Engineer with 4–7 years in validated environments to support equipment, utilities, facilities, computerized systems, and MES/eBR platforms in GMP-regulated settings.

You will develop, execute, review, and maintain validation documentation, ensuring data integrity and regulatory alignment while collaborating with Manufacturing, Quality, Engineering, and IT/OT teams.

Qualifications

• Bachelor's degree in a technical field and GMP exposure.
• 4-7 years of validation experience in regulated life sciences.
• Experience with MES/eBR validation and CSV activities.
• Familiarity with GMP, 21 CFR Part 11, and data integrity requirements.
• Experience with MES platforms is preferred.

Responsibilities

• Generate and maintain validation lifecycle documentation (IQ/OQ/PQ, validation plans, reports).
• Support MES and eBR implementation, qualification, and lifecycle management.
• Review requirements, risk assessments, traceability matrices, and deviations.
• Ensure alignment with GMP and regulatory requirements during validation activities.
• Assist with CAPAs, change controls, and system releases.
• Collaborate with Manufacturing, Quality, Engineering, and IT/OT teams.

Skills

GMP knowledge

Data integrity

Documentation skills

Analytical thinking

Cross-functional collaboration

Education

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

Tools

PAS-X

PharmaSuite

Syncade

Opcenter

Job description

Company Description

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

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.

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.

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.