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Full-Time

Validation Engineer Senior 1

Posted on 8/18/2023

CAI

CAI

1,001-5,000 employees

Engineering and consulting for critical facilities

Data & Analytics
Consulting
Enterprise Software

Senior

Cambridge, MA, USA

Category
Lab & Research
Biology & Biotech
Required Skills
Communications
Word/Pages/Docs
Requirements
  • BS in a science or engineering field or equivalent years of experience
  • 4-8 years' experience in commissioning and qualification in a regulated industry
  • Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), upstream, downstream, purification, recovery, building automation, or other pharmaceutical manufacturing processes
  • Excellent technical problem-solving and troubleshooting skills
  • High attention to detail
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
  • Ability to work independently, while supporting other team members
  • Expertise in Microsoft Word and Excel
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
  • Excellent oral and written communication skills 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
  • Developing documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
  • Responsible for protocol writing and execution (field verification) and development of summary reports at client sites
  • Planning / coordinating work and directing small teams in document development and / or execution

CAI offers a stimulating work environment for professionals passionate about improving operational readiness and productivity in quality-critical manufacturing and mission-critical facilities, especially in the pharmaceutical and medical device sectors. Employees at this company benefit from engaging in complex projects that enhance their skills in engineering, risk management, and process optimization, making it an appealing place for career development in these cutting-edge fields.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Growth & Insights
Headcount

6 month growth

-10%

1 year growth

-10%

2 year growth

-10%

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

INACTIVE