Sr. Validation Engineer

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 Sr. Validation Engineer with 7-11 years of experience to lead and 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 managing validation lifecycle documentation while ensuring compliance with regulatory expectations, data integrity requirements, and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert for validation and computerized systems, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or adjusted as needed.)

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, computerized systems, and other GMP-regulated assets.
• Provide QA/Validation oversight for MES and eBR implementation, qualification, and system lifecycle activities.
• Review and approve requirements, risk assessments, traceability matrices, validation plans, test protocols, deviations, change controls, and validation summary reports.
• Review eBR workflows and electronic manufacturing processes to ensure alignment with approved manufacturing procedures, master batch records, and GMP requirements.
• Ensure compliance with applicable regulatory requirements, including 21 CFR Part 11, GMP, data integrity, computerized systems validation (CSV), and industry best practices.
• Support deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities for MES/eBR and other GMP computerized systems.
• Oversee validation activities for internal and client technology transfer projects, including authoring, executing, reviewing, and closing validation documentation.
• Write, review, and revise qualification and verification documents, including SOPs, Validation Master Plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare comprehensive validation, verification, commissioning, qualification, and requalification summary reports.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, Manufacturing, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation and computerized systems.
• Lead periodic reviews and requalification activities for validated equipment, systems, and temperature-controlled assets.
• Collaborate closely with Manufacturing, Validation, Automation, IT/OT, Quality, and project teams to ensure validation activities align with project timelines and operational requirements.
• Provide technical mentorship and guidance to junior validation staff and project team members.

Qualifications and

REQUIREMENTS: Education

• Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field. Technical Experience
• 7-11 years of experience within the biotechnology, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, risk-based validation methodologies, and quality system requirements.
• Advanced validation expertise in equipment qualification, process validation, computerized systems validation (CSV), and automation systems.
• Demonstrated experience supporting MES and eBR validation, implementation, qualification, or lifecycle management activities within GMP manufacturing environments.
• Experience reviewing and approving validation documentation, including protocols, reports, requirements specifications, risk assessments, traceability matrices, and deviations.
• Extensive experience generating and executing IQ, OQ, PQ, CSV, and system qualification documentation.
• Experience supporting audits, regulatory inspections, remediation activities, and quality system compliance initiatives.
• Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar systems is strongly preferred. Knowledge, Skills, and Abilities
• Strong understanding of GMP manufacturing operations, 21 CFR Part 11 requirements, data integrity principles, and computerized systems validation methodologies.
• Demonstrated MES/eBR validation and qualification experience within regulated pharmaceutical or biotechnology environments.
• Excellent technical writing, documentation review, and validation reporting skills.
• Strong verbal and written communication skills, with the ability to effectively collaborate across Manufacturing, Quality, Validation, Automation, Engineering, and IT/OT organizations.
• Highly organized with strong analytical, problem-solving, and investigation skills.
• Ability to lead validation workstreams, manage multiple priorities, and work independently in a fast-paced environment.
• Experience supporting deviation investigations, root cause analysis, CAPAs, and change management activities.
• Ability to mentor junior engineers and contribute to team development and knowledge sharing.

Essential Functions

: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee i