Validation Engineer II/III

JOB SUMMARY

Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements. Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk assessments, and developing and maintaining quality system documentation, including SOPs, technical reports, and validation records. The position works cross-functionally to ensure projects are completed on schedule and in accordance with quality and regulatory expectations.

JOB 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.

SPECIAL WORK REQUIREMENTS

• Fully onsite position
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

COMPENSATION RANGE

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail