Full-Time

Computer System Validation Engineer

Confirmed live in the last 24 hours

CAI

CAI

1,001-5,000 employees

Consulting for operational readiness in healthcare

Biotechnology
Healthcare

Compensation Overview

$102.1k - $111.7kAnnually

Senior

No H1B Sponsorship

Dallas, TX, USA

Position requires onsite presence in Dallas, Texas.

Category
QA & Testing
Quality Assurance
Requirements
  • BS in a Computer Science or Engineering field or equivalent experience
  • 5+ years experience with Computer systems validation
  • Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is preferred
  • Experience in biotech and pharma is preferred over medical device
  • Experience with MES, Delta V, PI is a plus
  • Excellent oral and written communication skills in English/Fluent in English
  • Able to travel domestically and internationally as required
  • Able to work (paid) overtime
  • Able to work in the US without sponsorship now or any time in the future
Responsibilities
  • develop and execute protocols and test scripts
  • writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports

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

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • The partnership with Fedegari Group could lead to significant advancements in sterilization technology, benefiting both CAI and its clients.
  • CAI's focus on operational readiness and compliance can help clients achieve smoother transitions to full-scale production, potentially reducing costs and increasing efficiency.
  • Active involvement in professional societies and industry webinars positions CAI as a thought leader, enhancing its reputation and attracting top talent.

What critics are saying

  • The highly specialized nature of CAI's services may limit its market to specific sectors, potentially constraining growth opportunities.
  • Dependence on partnerships, such as with Fedegari Group, could pose risks if these collaborations face challenges or fail to deliver expected outcomes.

What makes CAI unique

  • CAI's specialization in operational readiness for the pharmaceutical, biotechnology, and healthcare sectors sets it apart from more generalized consulting firms.
  • Their strategic partnership with Fedegari Group to deliver turnkey sterilization solutions enhances their service offerings and provides a unique value proposition.
  • CAI's emphasis on professional development and industry collaboration ensures they remain at the forefront of industry trends and best practices.

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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