Senior Validation Engineer

Location: San Francisco, CA
Department: Azzur San Francisco, LLC

Job Description

Required Education:
• Bachelors Degree in engineering, science, or equivalent technical degree
Preferred Education:
• Masters Degree in engineering, science, or equivalent technical degree
Required Work Experience:
• 10+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
• Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
• Experience with project management
Preferred experience:
• Experience in Aseptic Manufacturing
• Experience in cell & gene therapy
Required Knowledge:
• Strong knowledge of FDA and cGMP regulations and documentation practices
Required expertise with multiple aspects of validation (equipment, process, cleaning, computer systems, and/or automation)
• Ability to manage projects and teams
• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Knowledge:
• Knowledge of cGMP requirements for EU
Skills (incl.Typical Mental Demands):
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
• Mathematical Skills
• Computer Skills
• Project Management
• Creating and fostering a team based environment
• Ability to oversee the work of subordinates and contractors while maintaining critical project schedules
• Coaching and mentoring skills
Additional Qualifications:
• Customer service/client relations
• Communication proficiency
• Attention to detail
• Can work productively independently with minor supervision
• Self-motivated, flexible, dependable and available
• Excellent organizational and time management skills 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.  


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