Job Description

The Quality Assurance Validation Engineer will oversee equipment, facilities, utilities qualification, and the associated systems lifecycle management activities for biologics with extensive focus on data integrity. This role offers a diverse breadth of accountability spanning all manufacturing equipment/processes, the embedded process automation systems, and analytical equipment. This individual will work closely with manufacturing, engineering and Quality Control, guiding the plan and design phase of projects and continuous process improvements in the manufacturing plant and lab environments. Supporting partners in identifying and navigating risk-appropriate qualification strategies will be critical to success in this role.

This is a 6 month contract hybrid schedule in Novato, California

Responsibilities

• Review and approve user requirement specifications, automation functional requirement specifications and software design documentation for automated facility, utility and equipment.
• Review and approve FAT’s, SAT’s, Commissioning and Automation Acceptance Testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports and final report packages of Facilities, Utilities and Equipment to support implementation of new systems, changes, revalidation and periodic review of existing systems.
• Experience with implementation of data integrity in a GMP environment.
• Define and document the data life cycle for GMP systems.
• Perform Data Integrity Risk Assessment and develop mitigation strategies to address risks.
• Implement technical and procedural controls to ensure data accuracy, consistency, and reliability.
• Ensure compliance with regulatory requirements and company policies related to data integrity, including FDA, EMA, and other relevant guidelines.
• Support internal and external audits by providing documentation and evidence of data integrity controls and practices.
• Continuously monitor and improve data integrity processes to enhance efficiency and compliance.

Qualifications

• Bachelor of Science in Engineering, Physical or Biological Sciences.
• 5+ years’ experience in a GMP regulated environment (Biotech or equivalent) with exhibited knowledge or proficiency in engineering.
• Experience in the review and approval of Validation and Qualification lifecycle documentation such as URS, IQ/OQ/PQ, Commissioning and Automation testing documentation.
• Proficiency in data management systems, software validation, data integrity principles and regulatory compliance.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Experience with participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred, but not required.
• Training in project management is preferred.
• Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Visio, MS Power Point.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus).
• Proficiency in technical documentation writing required.
• Experience in the review and approval of cleaning and sterilization validation protocols, reports and validation discrepancies is preferred but not required.

Pay

• $41.04-$51.30/hr

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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