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.

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

Work Requirements

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

Education & Certification

• Bachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline

Required Experience

• 5-8 years of validation experience
• Experience working in clean room environments
• Experience with aseptic fill finish technique
• Experience with validation lifecycle management and continued process verification

Required Knowledge, Skills & Abilities

• 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

Compensation

The anticipated annual salary range for the Validation Engineer II/III position is $105,000-$130,000. Actual annual salary and level will be determined based on relevant experience, skills and education.

Physical Demands & Work Environment

• Regularly sit for long periods of time
• 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
• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds
• Frequently utilize close vision and the ability to adjust focus
• Frequently required to communicate by talking, hearing, using telephone and e-mail

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Company Culture

Genezen is committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. We are committed to overcoming challenges, learning from failures, and persistently striving for success. We are dedicated to delivering quality results and upholding ethical principles. We are committed to being a proactive, collaborative, creative and open-minded partner.

This response is AI-generated, for reference only.