CQV Engineer at CAI

Milan, Lombardy, 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 Sciences, BiotechnologyIndustries

Requirements

Bachelor's or Master's degree in a relevant scientific or engineering field, or equivalent practical experience
At least 4-8 years of experience in commissioning and/or qualification activities within a regulated industry (FDA/AIFA)
Experience with startup of plants/equipment, inspections, and troubleshooting, including WFI, RO, HVAC, Building Automation, other pharmaceutical manufacturing processes, FAT/SAT, URS, P&ID, IQ/OQ/PQ, and protocol generation and execution
Strong knowledge of GMP processes
Execution and reporting of qualification protocols for isolators and VHP cycle development
Proficiency in Microsoft Word and Excel
Excellent written and spoken English

Responsibilities

Documenting commissioning, qualification, and validation activities
Writing and executing protocols
Conducting field verifications
Preparing summary reports at the client site
Providing leadership and guidance for the integration and delivery of CQV services to clients in the Life Sciences sector
Supporting onsite activities, including FAT, SAT, IOQ and PQ execution, and system walkdowns
Managing the lifecycle of C&Q documentation and execution, from SLIA generation to OQ completion
Supporting activities in biopharmaceutical manufacturing areas such as biotechnology, aseptic processing, aseptic filling/finishing, OSD, gene therapy, or equivalent experience
Travel within Italy and potentially Europe may be required

Skills

Key technologies and capabilities for this role

CQVFATSATURSP&IDIQOQPQGMPHVACWFIROBuilding AutomationVHPMicrosoft ExcelMicrosoft Word

Questions & Answers

Common questions about this position

What is the salary for the CQV Engineer position?

This information is not specified in the job description.

Is this CQV Engineer role remote or onsite?

The position is onsite in Italy.

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

Candidates need 4-8 years of experience in commissioning and qualification in regulated industries (FDA/AIFA), strong GMP knowledge, proficiency in protocol execution for isolators and VHP, experience with WFI, RO, HVAC, FAT/SAT, IQ/OQ/PQ, and excellent English skills. Proficiency in Microsoft Word and Excel is also required.

What does the team structure look like for this CQV Engineer position?

The role involves joining the growing Operations team.

What makes a strong candidate for the CQV Engineer position?

A strong candidate has a Bachelor's or Master's in a scientific or engineering field, 4-8 years of CQV experience in regulated pharma industries, hands-on knowledge of GMP, specific expertise in systems like WFI, HVAC, isolators, and protocol execution including FAT/SAT and IQ/OQ/PQ.

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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