Full-Time
CAI
1-10 employees
Consulting for operational readiness in healthcare
No salary listed
Senior
L'Aquila, Italy
Candidates must be available for travel throughout Italy and some European travel may be required.
- 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
- 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
- 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
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
- 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 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 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.
Help us improve and share your feedback! Did you find this helpful?
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