Validation Engineer Senior at CAI

Italy

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Mission CriticalIndustries

Requirements

Knowledge and experience in Validation approaches applied to Systems and processes
Experience managing Deviation/Change Control applied to validation study
Experience in Process Validation, cleaning validation, equipment qualification, filter validation
Ability to support generation of C&Q Procedures for client projects
Ability to support CQV review/qualification of equipment design
Ability to review and revise installation, operation, and performance qualification/verification related documents (e.g., SOPs, CAI Requisition Request validation/verification master plans, guidelines, and execution plans)
Strong cGMP and regulatory requirement understanding
Ability to interpret client’s needs, assess requirements, and identify solutions to non-standard requests
Ability to ensure the highest Quality, Compliance, and Safety standards
Project Management: Can reliably create resource loaded schedules; assumes personal responsibility for specific components of larger projects; creates strategies to balance short-term requirements with long-range business plans; pursues initiatives to capitalize on strengths, market opportunities, and counter threats; aligns strategic priorities with organizational direction
Ability to apply Commercial Insights: Demonstrates understanding of financial and economic levers that impact business performance; promotes best-in-class risk awareness and reviews risk management performance; draws appropriate conclusions from financial data

Responsibilities

Provide knowledge and experience in Validation approaches applied to Systems and processes
Manage Deviation/Change Control applied to validation study
Support generation of C&Q Procedures for client projects
Support CQV review/qualification of equipment design
Review and revise a variety of installation, operation, and performance qualification/verification related documents, including SOPs, CAI Requisition Request validation/verification master plans, guidelines, and execution plans
Interpret client’s needs, assess requirements, and identify solutions to non-standard requests
Ensure the highest Quality, Compliance, and Safety standards
Work collaboratively to facilitate client alignment and adoption of best practices for validation
Perform project management tasks, including creating resource loaded schedules and assuming responsibility for project components
Apply commercial insights to improve business performance and manage risks

Skills

Key technologies and capabilities for this role

Validation

Questions & Answers

Common questions about this position

What is the salary for the Validation Engineer Senior position?

This information is not specified in the job description.

Is this a remote position or what is the location requirement?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires knowledge in validation approaches for systems and processes, experience managing deviation/change control, process validation, cleaning validation, equipment qualification, filter validation, strong cGMP and regulatory understanding, and project management skills including creating resource-loaded schedules.

What is the company culture like at CAI?

CAI emphasizes relentless dedication to excellence, acting with integrity, serving each other and society, working for the future, bold thinking, creativity, and operational readiness as a way of life.

What makes a strong candidate for this Validation Engineer position?

Strong candidates will have hands-on experience in process validation, cleaning validation, equipment qualification, managing deviations and change control, strong cGMP knowledge, and the ability to create resource-loaded project schedules while ensuring quality, compliance, and safety.

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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