Full-Time
CAI
1-10 employees
Professional services for operational excellence
No salary listed
Senior
Pisa, Province of Pisa, Italy
Candidates must be available for travel throughout Italy and some European travel may be required.
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- High attention to detail
- Ability to multi-task and take initiative to accomplish assigned tasks accurately
- BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
- Minimum 4 – 8 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
- 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
- Expertise in Microsoft Word and Excel
- Excellent oral and written English are required
- Available for travel throughout Italy and some European travel may be required
- 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
- 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
- Familiarity with Baseline Guide 5 (Second Edition) a plus
- GMP based knowledge
- Qualification protocols execution and reporting
- Use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hood, filling lines, oral solid production equipment)
CAI provides professional services focused on enhancing operational readiness and excellence in critical environments. The company employs a team of experts in engineering, quality, and operations who utilize advanced technology to ensure that projects are completed on schedule and within budget. CAI distinguishes itself from competitors by emphasizing continuous improvement and fostering genuine connections with clients, which helps to maintain high standards in their work. The primary goal of CAI is to lead the industry and contribute to building a better future.
Company Size
1-10
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Overland Park, Kansas
Founded
1996
Simplify's Take
What believers are saying
- Demand for digital transformation in life sciences boosts CAI's automation consulting services.
- Personalized medicine trends create opportunities for flexible manufacturing process consulting.
- Data centers' focus on energy efficiency aligns with CAI's energy management expertise.
What critics are saying
- Competition from specialized firms in digital transformation may erode CAI's market share.
- In-house consulting teams in corporations could reduce demand for CAI's services.
- Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.
What makes CAI unique
- CAI offers comprehensive consulting services across multiple industries, including life sciences.
- Their expertise in energy management aligns with the sustainability focus of data centers.
- CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.
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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