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

Requirements

Candidates should possess a Bachelor’s degree in a relevant science or engineering field, or equivalent years of hands-on experience, with a minimum of 4-8 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry. They should have a strong understanding of typical project technical issues and deadlines, and be proficient in life science manufacturing processes, including biotech, aseptic processing, aseptic fill/finish, OSD, and Gene Therapy. Familiarity with Baseline Guide 5 (Second Edition) is considered a plus.

Responsibilities

The Validation Engineer will develop documentation to support Commissioning, Qualifications, and Validation, including protocol writing and execution, field verification, and development of summary reports at client sites. They will support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment, and provide cGMP leadership and guidance for the integration and delivery of CQV services. The role involves managing the C&Q documentation and execution lifecycle, supporting onsite and offsite activities such as FATs, SATs, IOQ and PQ Executions and System Walkdowns, and demonstrating expertise in GMP based knowledge, qualification protocols execution and reporting, and use of calibration instruments for pharmaceutical equipment testing.

Skills

CQV

GMP

IQ/OQ/PQ

FAT/SAT

URS

P&IDs

HVAC

WFI

Protocol Writing

Protocol Execution

Troubleshooting

Microsoft Excel

Microsoft Word

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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