Validation Engineer with expertise in isolators and VHP Cycle development. at CAI

Milan, Lombardy, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Life SciencesIndustries

Requirements

BS or MS in a relevant science or engineering field, or equivalent hands-on experience
Minimum 3–5 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry
Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation, pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs generation & execution
Expertise in isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues and deadlines
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
Familiarity with Baseline Guide 5 (Second Edition) a plus
Expertise in Microsoft Word and Excel
Excellent oral and written English
Available for travel throughout Italy and some European travel; valid permit to stay for Italy

Responsibilities

Develop documentation to support Commissioning, Qualifications, and Validation of pharmaceutical facilities, utilities, and equipment
Write and execute protocols (field verification), and develop summary reports at client sites
Execute isolators qualification protocols and reporting, VHP cycle development
Provide cGMP leadership and guidance for the integration and delivery of VALIDATION services for Life Sciences clients
Manage 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
Create strategies to balance short-term requirements with long-range business plans
Pursue meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats
Align strategic priorities of own area with current direction and strategic priorities of the broader organization

Skills

Validation Protocols

Commissioning

Qualification

Isolators

VHP Cycle Development

GMP

cGMP

FAT

SAT

URS

P&IDs

HVAC

WFI

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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