Full-Time

Validation Engineer

Confirmed live in the last 24 hours

CAI

CAI

1-10 employees

Professional services for operational excellence

No salary listed

Senior

L'Aquila, Italy

Candidates must be available for travel throughout Italy and some European travel may be required.

Category
QA & Testing
Quality Assurance
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
  • High attention to detail
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately
  • BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
  • Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
  • Ability to work independently, while quickly building and nurturing a project team
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
  • Expertise in Microsoft Word and Excel
  • Excellent oral and written English are required
Responsibilities
  • Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
  • Responsible for protocol writing and execution (field verification), and development of summary reports at client sites
  • Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
  • Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
  • Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
Desired Qualifications
  • Familiarity with Baseline Guide 5 (Second Edition) a plus
  • GMP based knowledge
  • Qualification protocols execution and reporting
  • Use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hood, filling lines, oral solid production equipment)

CAI provides professional services focused on enhancing operational readiness and excellence in critical environments. The company employs a team of experts in engineering, quality, and operations who utilize advanced technology to ensure that projects are completed on schedule and within budget. CAI distinguishes itself from competitors by emphasizing continuous improvement and fostering genuine connections with clients, while maintaining high standards in all its endeavors. The primary goal of CAI is to lead the industry and contribute to building a better future.

Company Size

1-10

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Overland Park, Kansas

Founded

1996

Simplify Jobs

Simplify's Take

What believers are saying

  • 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.

What critics are saying

  • 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.

What makes CAI unique

  • 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.

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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