Validation Engineer at CAI

Pisa, Tuscany, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Life SciencesIndustries

Skills

Key technologies and capabilities for this role

CQVGMPIQ/OQ/PQFAT/SATURSP&IDsHVACWFIROProtocol WritingProtocol ExecutionTroubleshootingMicrosoft ExcelMicrosoft Word

Questions & Answers

Common questions about this position

What is the salary for this Validation Engineer position?

This information is not specified in the job description.

Is this Validation Engineer role remote or onsite?

The position is onsite in Italy.

What experience and skills are required for this CQV Engineer role?

Candidates need 4-8 years of experience in commissioning and qualification in an FDA regulated industry, excellent technical problem-solving skills, GMP knowledge including protocol execution, and proficiency in Microsoft Word and Excel. Excellent oral and written English is required, along with experience in pharmaceutical processes like utilities, FAT/SAT, IQ/OQ/PQ.

Does this role require travel?

Yes, candidates must be available for travel in Italy and abroad.

What makes a strong candidate for this Validation Engineer position?

Ideal candidates have field experience in facilities and equipment startup, utilities like WFI/RO/HVAC, FAT/SAT, URS, IQ/OQ/PQ execution, and GMP knowledge for pharmaceutical equipment testing.

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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