Validation Engineer II/III - GMP/Cell Therapy

Genezen; Lexington (VA); On-site; USD 105,000 - 130,000; Full time

Benefits offered by this job

Paid vacation days

Paid sick time

401(k) plan with company match

Dental & vision care

FSA and HSA programs

Volunteer day

Job summary

Genezen is seeking a Validation Engineer II/III to support validation and manufacturing operations, including equipment, utility, facility, and process qualification activities. You will assist in process transfers, scale-up, and process validation while ensuring compliance with cGMPs and regulatory requirements.

Responsibilities include protocols, reports, SOPs, risk assessments, and maintaining quality system documentation.

Qualifications

• Strong interpersonal and communication skills, both verbal and written, with demonstrated experience preparing technical documents such as protocols, reports, SOPs, and risk assessments.
• Ability to work collaboratively as part of cross-functional teams maintaining effective communication with project team members to achieve project objectives including effectively reporting project activity in a clear and concise manner.
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Visio, with the ability to develop technical documentation, analyze data, and create process flow diagrams.
• Demonstrated ability to effectively manage competing priorities, adapt to changing business needs, and meet challenging deadlines in a fast-paced environment while maintaining quality, compliance, and adherence to project timelines.
• Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 1 and 11, data integrity guidances, ICH guidelines with the ability to assess compliance risks.

Responsibilities

• Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
• Review and approve qualification documentation on behalf of the validation department.
• Ensure performance of all qualification activities is in accordance with internal procedures, industry best practices and regulatory guidance.
• Support investigations in protocol nonconformances, deviations discrepancies, and failures. Support root-cause investigations and development of appropriate CAPAs.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Author standard operating procedures related to validation practices.
• Review engineering and technical documentation, including P&IDs, equipment specifications, drawings, manuals, and functional/design specifications.
• Support commissioning and startup activities and ensure appropriate transition from commissioning to qualification
• Support the execution and generation of formal risk assessments.
• Support the generation and implementation of validation programs.
• Identify opportunities to improve validation processes, reduce execution timelines, and increase operational efficiency while maintaining compliance.
• Support audits and regulatory inspections, as needed.

Skills

Interpersonal skills

Verbal communication

Written communication

SOPs

Risk assessments

Cross-functional teamwork

MS Office

Excel

Word

PowerPoint

Visio

GxP regulations

ICH guidelines

Education

Bachelor’s degree in Engineering/ Biotechnology/ Biological Sciences/ related technical discipline

Tools

Microsoft Visio

Job description

Genezen is seeking a Validation Engineer II/III to support validation and manufacturing operations, including equipment, utility, facility, and process qualification activities. You will assist in process transfers, scale-up, and process validation while ensuring compliance with cGMPs and regulatory requirements.

Responsibilities include protocols, reports, SOPs, risk assessments, and maintaining quality system documentation.