Full-Time
CQV Engineer
Confirmed live in the last 24 hours
CAI
1-10 employees
Consulting for operational readiness in healthcare
Junior, Mid
Athens, GA, USA
Hybrid position in Athens.
- BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
- Minimum 2 – 5 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry
- Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution
- 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
- Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
- Familiarity with Baseline Guide 5 (Second Edition) a plus
- Expertise in Microsoft Word and Excel
- Excellent oral and written English are required
- Available for travel
- Support 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
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
- Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
- Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
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'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