GxP Lab Computing Analyst ( second shift

Work Hours: This role will require the successful candidate to work between the hours of 2:00 p.m.

- 10:00 p.m. Eastern.

Employment: This role will require full-time on-site presence at our client site in Cambridge, MA.

Relocation: This role is NOT eligible for relocation assistance.

The Zifo Lab Computing Analyst provides consulting, analytical, and technical laboratory services, including multivendor instrument, information technology and in-lab validation/compliance services when applicable. The individual will analyze customer needs and gaps to propose solutions, working with business users and managers in conjunction with the internal Zifo support team.

Location: Cambridge, MA

• Requirements Management and onsite Validation/Compliance support
• IT Consulting
• Customer Liaison
• Onsite Lab IT Support

• Understand problem statement/challenges
• Define scope
• Gather requirements
• Assist with Validation/Compliance activities (IOPQ) as required
• Analyze current state business processes and requirements
• Assist in building plans for process improvement

• Analyze gaps/opportunities for improvement based on industry best practice
• Evaluate industry trends to identify areas for optimization
• Evaluate vendor solutions and facilitate demos of prototypes as proofs of concept
• Recommend process improvements that fit business needs

• Meet with internal/external service groups/leads
• Liaise between System/Lab owners and third parties to coordinate best times for services
• Provide weekly planning schedules for review at status meetings with customer leads
• Monthly operational review meetings / quarterly metrics reporting with department heads

• Perform break/fix support for all instrument-connected systems
• Implement Windows-based security policies as required
• Ensure adherence to client corporate policies through periodic reporting and compliance programs
• Act as the technical support contact for field service engineers and external vendors
• Provide technical subject matter expertise for new system validation and change management
• Create and maintain a physical inventory of lab equipment, PCs, software, and other relevant assets
• Perform system preventive maintenance based on client schedule

• Bachelor's or Master’s degree (or equivalent) in Pharmaceutical, Biotechnology, Biomedical, Chemical engineering
• At least 4 years of directly relevant experience, including:
  • At least 1 year in software development and testing
  • At least 1 year of experience in business requirement analysis and gathering
  • Demonstrated domain knowledge and excellent analytical and interpersonal skills, proven track record in system design and implementation, leadership, client trust
  • In-depth understanding of at least one of the following Bio/Pharma areas:
    • Drug Discovery & Development Processes
    • Clinical study planning & Data management
    • Lab Workflows
    • Chemical & Biologics material Management
    • Sample Management
    • Robotic Systems Integration & Qualification
    • Operations KPI and Metrics tracking
  • Optional:
    Familiarity with US and international regulations such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820
• Technical
  
  Skills:
  • Operating system familiarity with at least one of Unix, Windows, MVS
  • Software methodology familiarity with Object Oriented Programming or Structured Programming
  • Software development process familiarity with Waterfall or Agile
  • Change Control Management and Risk Management
  • Office tools proficiency in MS Word, Excel, PowerPoint; optionally Visio, MS Project, Share Point

Competitive compensation package including accrued vacation, medical, dental, vision, 401(k) with company matching, life insurance, and flexible spending accounts.

Zifo is an equal opportunity employer and we value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.