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
