One of DAVIS’ Pharmaceutical Solutions clients is looking to hire a Validation Engineer on a contract to direct basis. This position requires validation experience in pharmaceuticals. 

Validation Engineer Job Requirements:

• Plan, schedule, execute, and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy, and re-validation of existing computerized systems with customers in Cambridge area.
• Evaluate, define, and develop clients’ technical needs and make recommendations
• Prioritize, manage, and execute multiple projects utilizing Project Management methodology
• Perform business development activities with both new and existing clients
• Directly manage assigned projects to satisfy specific project/client needs
• Promote client-based and solutions approach
• Generation / execution of System Impact and Critical Aspect Assessment Impact
• Coordinate and interface with project managers, as well as engineering and quality assurance groups to ensure successful project execution
• Lead cross-functional project teams in the development of validation deliverables
• Review and approve validation project documentation
• Develop validation deliverables including master plans, protocols and summary reports, as required
• Support development of best practices within the validation group, based on current industry practices and guidelines
• 8+ years of end to end full life cycle computer systems validation; risk assessments, gap analysis, gather requirements, URS, FRS, DS, write/execute script, validation Summary report, etc.
• Will need experience with decommissioning and/or very strong understanding of decommissioning and systems retirement
• Strong documentation skills and experience. Will be doing assessments and writing full decommissioning documents (template provided) will also be responsible for producing: hand over documents, training doc and more.
• Must have strong problem solving capabilities and ability to work on your own. Need a ‘get the job done’ attitude.
• Should have a mix of systems experience – ERP, lab system, Manufacturing, Packaging systems. Follow clients SOP
• Candidate should have knowledge of GLP, GMP and GCP: Should understand infrastructure qualification as well; good understanding of GAMP5

Validation Engineer Preferred Qualifications

• Bachelors degree in computer science, computer engineering, life science, or any other pertinent degree
• Minimum of 10 years of experience in a highly regulated environment: pharmaceutical, biotechnology or related industry
• 2 to 3 years of experience in project management (preferred)
• In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
• Familiar with off-the-shelf, configurable, and custom-developed applications
• In-depth knowledge of validation deliverables associated with each step of the computer system life cycle
• Experience with various technologies and automated systems used in the pharmaceutical industry: e.g. Information Management, Business System, PLC or SCADA, Process Control, laboratory instrumentation, data archive, etc.
• Experience in process automation an asset
• Familiar with computer system infrastructure, including: networks, servers, related hardware and supporting software, and peripheral hardware
• Possess strong analytical and decision-making skills
• Possess excellent English verbal and written communication skills for interface with management, lead strategists and systems owners and be able to produce quality deliverables.
• Quality experience is a plus.
• Data Migration or Data Archiving exp is a huge plus!
• Position demands an individual who is willing to travel

Interested?Apply for the Validation Engineer position – click here!