Full-Time

Senior Validation Engineer

Confirmed live in the last 24 hours

CAI

CAI

1-10 employees

Consulting for operational readiness in healthcare

AI & Machine Learning

Compensation Overview

$87.1k - $120.2kAnnually

Senior, Expert

No H1B Sponsorship

Raleigh, NC, USA

This position is onsite in Raleigh, North Carolina.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
  • BS in a science or engineering field or equivalent years of experience
  • 4-12 years' experience in commissioning and/or qualification activities in a regulated industry
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
  • High attention to detail
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
  • Ability to work independently, while quickly building and nurturing a project team
  • Expertise in Microsoft Word and Excel
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
  • Experience in planning / directing C&Q activities a plus
  • Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
  • Excellent oral and written communication skills in English/Fluent in English
  • Able to travel domestically and internationally as required
  • Able to work in the US without sponsorship now or any time in the future.
Responsibilities
  • develops the documentation to support Commissioning, Qualifications, and Validation
  • responsible for protocol writing and execution, field verification, and development of summary reports at the client site
  • planning / coordinating work and directing small teams in document development and / or execution

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Overland Park, Kansas

Founded

1996

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased demand for digital transformation boosts CAI's consulting services in life sciences.
  • Industry 4.0 creates opportunities for CAI in automation and data analytics.
  • Data centers' focus on energy efficiency aligns with CAI's energy management services.

What critics are saying

  • Competition from specialized firms in digital transformation and AI integration is rising.
  • Demand for sustainability consulting may outpace CAI's current environmental offerings.
  • Rapid data center technology evolution could render CAI's services outdated.

What makes CAI unique

  • CAI offers comprehensive consulting across life sciences, data centers, and process manufacturing.
  • Their services include project management, risk management, and energy management.
  • CAI integrates new technologies into existing processes, enhancing operational efficiency.

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Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country