CQV Engineer at CAI

Rome, Lazio, 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
Minimum 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, pharmaceutical production equipment, FAT/SAT, URS, P&ID, IQ/OQ/PQ, and generation and execution of documentation
High attention to detail
Multitasking and initiative to complete assigned tasks accurately
Problem-solving and technical troubleshooting skills
Independent work style with team collaboration
Management of the CQV lifecycle, from SLIA generation to OQ completion
Support of onsite activities: FAT, SAT, IOQ and PQ execution, and system walkdowns
Experience in Life Sciences production processes (biotechnology, aseptic processing, aseptic filling/finishing, OSD, gene therapy, or equivalent)
Familiarity with Baseline Guide 5 (Second Edition) is a plus
Proficiency in Microsoft Word and Excel
Excellent spoken and written English language skills

Responsibilities

Document commissioning, qualification, and validation activities
Write and execute protocols
Perform field verification
Prepare summary reports at the client site
Provide leadership and guidance for the integration and delivery of CQV services to clients in the Life Sciences sector
Support onsite activities, including FAT, SAT, IOQ and PQ execution, and system walkdowns
Manage the lifecycle of C&Q documentation and execution, from SLIA generation to OQ completion
Assist with the execution and reporting of qualification protocols for isolators
Develop VHP cycle processes
Apply GMP knowledge

Skills

CQV

FAT

SAT

URS

P&ID

WFI

HVAC

Building Automation

Microsoft Word

Microsoft Excel

Aseptic Processing

Biotechnology

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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