CSV Engineer

• Location: vista
• Type: Direct Hire
• Job #37077

Great opportunity with one of the largest API manufacturers for the Pharma/Biotech industry!

The CSV Engineer fulfills a critical role in GMP operations, supporting computer system validation activities for API and PMO manufacturing, for computerized system attached to equipment, facilities, utilities.

Your Tasks

• Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
• Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP, etc.)
• Work directly with local and Central QA departments
• Participate in site projects and manage all activities in regards to validation and qualification of computer systems and applications
• Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors

Your Profile

• Bachelors’ degree in computer science, engineering or science discipline required
• Minimum of 5 years of hands-on experience in computer system validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
• Proven track record in validation and qualification of complex computer systems
• Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards
• Experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP, Specifications, Risk assessments)
• Excellent written and oral communication skills
• Excellent computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment
• Experience in a cGMP environment required
• General lab instrumentation knowledge and operation experience
• Capable of working methodically and accordingly adhering to rules and regulations.
• Entering or recording information in written or electronic form
• Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things
• Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment.
• Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as necessary)

Preferred

• Master’s degree in science related field (computer science, engineering, science)
• Experience with Equipment, Facility, and Utility System Qualification (IQ, OQ, PQ)
• Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems
• Experience with audit/inspection presentations, and strong technical communication skills