QA/Validation Engineer at CAI

Milan, Lombardy, Italy

CAI Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Skills

Key technologies and capabilities for this role

cGMPTrackwiseDeviation ControlChange ControlLaboratory InvestigationsEnvironmental MonitoringBatch DispositionBatch Record ReviewCertification Oversight

Questions & Answers

Common questions about this position

What is the salary for this QA/Validation Engineer position?

This information is not specified in the job description.

Is this QA/Validation Engineer role remote or onsite?

The position is onsite in Italy and abroad, with availability for travel required.

What skills are required for the QA/Validation Engineer role?

Key requirements include knowledge and experience in Quality Systems/Operational Quality (e.g., Deviation/Change Control, Laboratory Investigations, Environmental Monitoring), strong cGMP and regulatory understanding, experience with Trackwise, and excellent oral and written English skills.

What is the company culture like at CAI?

The company emphasizes collaboration to facilitate client alignment and best practices, respects equal opportunities, and prioritizes the highest Quality, Compliance, and Safety standards.

What makes a strong candidate for this QA/Validation Engineer position?

Strong candidates will have hands-on experience in Quality Systems like Deviation/Change Control and cGMP, proficiency with Trackwise, and the ability to solve complex problems while ensuring regulatory compliance; excellent English and travel availability are also essential.

CAI

Consulting for operational readiness in healthcare

About CAI

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.

Overland Park, KansasHeadquarters
1996Year Founded
$3.4MTotal Funding
PRE_SEEDCompany Stage
Industrial & Manufacturing, Biotechnology, HealthcareIndustries
1-10Employees

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

Risks

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.

Differentiation

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.

Upsides

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.

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