Validation Engineer at CAI

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life SciencesIndustries

Requirements

Experience leading commissioning, qualification, and validation activities in a GMP environment with focus on safety, quality, compliance, data integrity, and regulatory expectations (e.g., ALCOA+ principles)
Knowledge of qualifying packaging equipment (e.g., vial labellers, cartoners, carton labelling systems, vision systems, printers/coders, handling/inspection equipment)
Expertise in validating serialization and aggregation systems, market-specific packaging formats (e.g., artwork, label content, pack configuration, tamper evidence, variable data, serialization rules)
Ability to create and review validation documentation (e.g., Validation Master Plans (VMPs), URS, IQ/OQ, IV/FV, FV, PQ protocols) ensuring audit-readiness
Capability to plan, execute qualifications, oversee FAT/SAT, commissioning, manage deviations/CAPAs, and support design reviews/shakedown
Proficiency in project scoping, planning, execution, progress tracking, vendor/stakeholder coordination, and cross-functional collaboration (e.g., with Engineering, Operations, QA, IT)
Skills in troubleshooting issues, risk mitigation, providing design input, and achieving right-first-time outcomes

Responsibilities

Lead end-to-end validation activities for packaging and combination product assembly lines in GMP environment, focusing on safety, quality, and compliance
Plan and execute qualifications, oversee FAT/SAT and commissioning activities, manage deviations/CAPAs
Partner with Engineering, Operations, QA, and IT teams to troubleshoot and resolve issues
Create and review validation documentation including VMPs, URS, IQ/OQ, IV/FV, FV, PQ protocols, ensuring audit-readiness and ALCOA+ compliance
Qualify packaging equipment (e.g., vial labellers, cartoners, labelling systems, vision systems, printers/coders, handling/inspection equipment)
Validate serialization and aggregation systems for data accuracy and regulatory compliance
Support design reviews, shakedown, commissioning, FAT, IQ/OQ/PQ activities
Support scoping, planning, and execution of validation projects aligned with schedules
Lead vendor and stakeholder engagement during FAT/SAT to meet deliverables
Validate market-specific packaging formats covering artwork, labels, pack configuration, tamper evidence, variable data, serialization rules

Skills

Validation

Commissioning

Qualification

FDA

Project Management

Operational Readiness

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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